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The FDA Advances New Proposed Regulation of the 16 Currently Marketed Active Ingredients, Two Ingredients – Zinc Oxide and Titanium Dioxide are Generally Recognized as Safe and Effective for use in Sunscreens

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The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.

The agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded.

Over the last twenty years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered GRASE.

In the proposed rule, the FDA makes the following proposals for sunscreens marketed without FDA-approved applications:

Based on existing data FDA also has concluded that two active ingredients, PABA (amino benzoic) and trolamine salicylate are unsafe and therefore are Category II.  Based on information available to FDA, these two active ingredients are not currently used in any sunscreens currently marketed in the United States.

According to the FDA, the Category III sunscreen ingredients lack enough data to support whether they are generally recognized as safe and effective and states that existing evidence suggests that these active ingredients are, or may be, absorbed through the skin, and data about the consequences of this absorption are missing. The 12 Category III sunscreen ingredients are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.

Two ingredients – zinc oxide and titanium dioxide are both mineral sunscreens that do not penetrate and are not absorbed through the skin and are generally recognized as safe and effective for use in sunscreens. The FDA has sufficient evidence that they are GRASE Category I. Thus, the safety evaluation does not need to consider more than direct effects on the skin.

Love Sun Body 100% Natural Origin Mineral Sunscreens are made with the safest UVA and UVB filters - SPF 30 formulas non-nano zinc oxide and SPF 50 formulas non-nano zinc oxide and titanium dioxide and plant based moisturizers.

Love Sun Body 100% Natural Origin Mineral Sunscreens are the first and only sunscreens in the U.S. certified by Ecocert Cosmos Natural and have been clinically tested hypoallergenic, non-comedogenic and are reef safe.

Love Sun Body 100% Natural Origin Mineral Sunscreens meet the regulatory requirements of the FDA OTC Monograph System and the European Commission’s recommendation on UVA protection.

Love Sun Body was also recently given the best score for safety and efficacy by the Environmental Working Group (EWG). Love Sun Body sunscreen formulas are certified PETA Cruelty Free and Vegan, with no eye stinging ingredients.

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