FDA Allowable Ingredients in Sunscreens

January 19, 2010 by admin · Leave a Comment 

The following are the FDA allowable active ingredients in sunscreens:

UV-filter

Other names

Maximum concentration

Permitted in these countries

Results of safety testing

p-Aminobenzoic acid PABA 15% (5% EC-will be banned from sale to consumers from 8 October 2009) EC, USA, AUS Protects against skin tumors in mice. Shown to increase DNA defects, however, and is now less commonly used.
Padimate O OD-PABA, octyldimethyl-PABA, σ-PABA 8% (EC,USA,AUS) 10% (JP)

(Not currently supported in EU and may be delisted)

EC, USA, AUS, JP Not tested
Phenylbenzimidazole sulfonic acid Ensulizole, Eusolex 232, PBSA, Parsol HS 4% (US,AUS) 8% (EC) 3% (JP) EC,USA, AUS, JP Genotoxic in bacteria
Cinoxate 2-Ethoxyethyl p-methoxycinnamate 3% (US) 6% (AUS) USA, AUS Not tested
Dioxybenzone Benzophenone-8 3% USA, AUS Not tested
Oxybenzone Benzophenone-3, Eusolex 4360, Escalol 567 6% (US) 10% (AUS,EU) 5% (JP) EC, USA, AUS, JP Not tested
Homosalate Homomethyl salicylate, HMS 10% (EC, JP) 15% (US,AUS) EC, USA, AUS, JP Not tested
Menthyl anthranilate Meradimate 5% USA, AUS Not tested
Octocrylene Eusolex OCR, 2-cyano-3,3diphenyl acrylic acid, 2-ethylhexylester 10% EC,USA, AUS, JP Increases ROS
Octyl methoxycinnamate Octinoxate, EMC, OMC, Ethylmethoxycinnamate, Escalol 557, 2-ethylhexyl-paramethoxycinnamate, Parsol MCX 7.5% (US) 10% (EC,AUS)20% (JP) EC,USA, AUS, JP
Octyl salicylate Octisalate, 2-Ethylhexyl salicylate, Escalol 587, 5% (EC,USA,AUS) 10% (JP) EC,USA, AUS, JP Not tested
Sulisobenzone 2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid,

3-benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid, Benzophenone-4, Escalol 577

5% (EC) 10% (US, AUS, JP) EC,USA, AUS, JP
Trolamine salicylate Triethanolamine salicylate 12% USA, AUS Not tested
Avobenzone 1-(4-methoxyphenyl)-3-(4-tert-butylphenyl)propane-1,3-dione, Butyl methoxy dibenzoylmethane, BMDBM, Parsol 1789, Eusolex 9020 3% (US) 5% (EC,AUS)10% (JP) EC, USA, AUS, JP Not available
Ecamsule Mexoryl SX, Terephthalylidene Dicamphor Sulfonic Acid 10% EC,AUS (US:Approved in certain formulations up to 3% via New Drug Application (NDA) Route) Protects against skin tumors in mice
Titanium dioxide CI77891 25% (No limit Japan) EC,USA, AUS, JP Not tested
Zinc oxide 25% (US) 20% (AUS)

(EC-25% provided particle size >100 nm) (Japan, No Limit)

EC,USA, AUS, JP Protects against skin tumors in mice

Many Sunscreen Products are Harmful to Health

January 17, 2010 by admin · Leave a Comment 

For 29 years, the FDA has refused to publish safety standards for sunscreen products. That’s nearly three decades of keeping the public in the dark about the extremely harmful, cancer-causing chemicals found in sunscreen products. Any idea why the Food and Drug Administration has taken so long to set safety standards for a product used by over 100 million Americans? If you guessed, “Because the greedy corporations selling the toxic sunscreen products don’t want the FDA to study the safety of their products,” give yourself golden star sticker. You got it! The FDA has no interest in protecting the public from cancer-causing personal care products, and that simple fact is made abundantly clear by the FDA’s 29-year delay to establish basic safety guidelines.

As is increasingly the case, non-profit groups are now doing the job the FDA should be doing but refuses to do. In this case, the Environmental Working Group (www.EWG.org), one of my top recommended non-profit organizations, has compiled a list of 700 name-brand sunscreens along with the toxic chemicals they contain. You’ll find the list at http://www.ewg.org/sunscreen/

As the EWG reports, many sunscreen products contain cancer-causing chemicals that get absorbed right through the skin:

Some sunscreens absorb into the blood and raise safety concerns. Our review of the technical literature shows that some sunscreen ingredients absorb into the blood, and some are linked to toxic effects. Some release skin-damaging free radicals in sunlight, some act like estrogen and could disrupt hormone systems, several are strongly linked to allergic reactions, and still others may build up in the body or the environment. FDA has not established rigorous safety standards for sunscreen ingredients.

After 29 years of debate, the government has failed to set mandatory sunscreen safety standards. Companies are free to make their own decisions on everything from advertising claims to product quality. In lieu of setting final standards, the Food and Drug Administration (FDA) advises people to stay out of the sun from 10 am to 4 pm. FDA now stands in direct violation a Congressional mandate requiring the agency to finalize sunscreen safety standards by May 2006, flouting not only Congress but also consumers, who are reliant on sunscreen to protect their health.

84% of sunscreen products harm consumers
As the EWG’s research reveals, an incredible 84% of sunscreen products are harmful to consumers. You read that right: More than four out of five sunscreen products actually harm the people who use them.

FDA wants the labeling on your sunscreen to tell you more about protection against the sun’s harmful rays

January 17, 2010 by admin · Leave a Comment 

Under a new regulation, the agency has proposed that sunscreen labeling be expanded to provide

• A four-star rating system that informs consumers how well the product protects them against “Ultraviolet A” (UVA) light.

• Information on other ways people can limit their risks to dangers posed by overexposure to sunlight.

What do “UVA” and “UVB”stand for?

UVA and UVB are types of ultra­violet (UV) radiation emitted by the sun. Although the atmosphere’s ozone layer shields us from most of this radiation, the UV light that gets through can cause problems. UVB light is primarily responsible for sunburn. UVA light penetrates the skin more than UVB light does, and causes tanning. Both types of UV light contribute to premature skin aging, skin cancer, and other types of skin damage..

Currently, sunscreen labels are required to carry a “Sunburn Protec­tion Factor” (SPF) value that informs potential users how well the product protects against UVB light.

The Four-Star System.

Under the proposed regulation, a UVA star rating would be promi­nently displayed on sunscreen labels, near the SPF rating..

“For more than 30 years, consum­ers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values,” said Andrew C. von Eschenbach, M.D., Commissioner, Food and Drugs. Under this proposal, “consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun.”

With the proposed UVA rating system.

• One star will represent low UVA protection
• Two stars, medium protection
• Three stars, high protection
• Four stars, the highest UVA protection available in an over-the-counter (OTC) sunscreen product.
• If a sunscreen product does not rate at least one star, FDA is proposing that its labeling bear a “no UVA protection” marking on the front label, near the SPF value.

Sunscreen Not the Only Option.

In addition to the new rating system, FDA wants sunscreen labels to advise consumers that using a sunscreen is just one way they can protect them­selves against the sun. Limiting time in the sun and wearing protective clothing as part of a comprehensive sun protection regimen are other rec­ommendations that would be promi­nently displayed on labels. Using sunscreens liberally and reapplying frequently would also be advised.

Changes With SPFs, Too.

FDA also wants to make changes regarding protection against UVB light. The agency has proposed amending its existing rule on UVB products to increase the maximum sunburn protection factor from SPF 30+ to SPF 50+.

The proposed rule is asking the pub­lic to comment on the use of nanopar­ticle ingredients in sunscreens, and is proposing to

• make minor changes in SPF (UVB) testing procedures consistent with current science, to further enhance the accuracy of SPF values.
• allow new combinations of active ingredients.

Top Five Sun Care Picks From EWG

May 22, 2009 by admin · Leave a Comment 

We’ve established the importance of sun care, for your baby, and the entire family. At this time there aren’t any safety standards set by the FDA for sunscreens. So it is important for parents to know what they are truly rubbing into their baby’s bodies. A good example of the standards set for our sunscreens is the use of PABA (”a skin damaging chemical”, EWG) that was more widely used in the past. It still is, however, since there was an outcry from consumers with allergic reactions, companies use it less.

The bottom line is that we parents need to be aware that some sunscreens may be potentially more harmful than good. “Studies show that some traditional sunscreens like oxybenzone and octinoxate definitely absorb into healthy skin – in large amounts according to some studies – and act like estrogens in the body, raising risks for breast cancer, and showing effects like hormone-driven uterine damage in other studies”. 1

Take a look at your current sunscreen and you will probably find one of these ingredients, if not both. There is also some controversial concern with the micro sized (nanosize) titanium and zinc. Are these particles so small that they can absorb through the skin and into our blood stream? For now it is considered safe (as long as the particles aren’t too small) on healthy skin. A good way to test is this, if the sunscreen rubs clear onto your baby’s skin, it is nanosized. If it rubs on with some white, the particles are not too small.

Below we’ve listed the top five choices according to the Environmental Working Group. We always suggest, however, to do your own homework and then you can make an educated decision as to what is right for your family.

Environmental Working Groups Safest Sunscreen Picks

1. Keys Soap Solar Rx Therapeutic Sunblock
2. Trukid Sunny Days Facestick Mineral Sunscreen UVA/UVB Broad Spectrum
3. California Baby Sunblock Stick No Fragrance
4. Badger Sunscreen
5. Marie Veronique Skin Therapy Sun Serum

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