Export Compliance | Sharing of Current Status and Compliance Points of Sun Protection Products Supervision by the US FDA,Comprehensive general

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Export Compliance | Sharing of Current Status and Compliance Points of Sun Protection Products Supervision by the US FDA

Current Status of Sunscreen Product Regulation in the United States

● Background

The FDA regulates sunscreen products to ensure they meet safety and efficacy standards. In order to improve the quality, safety, and effectiveness of sunscreen products, the FDA issued a proposed order on September 24, 2021, which describes the latest proposed requirements for sunscreen products. Sunscreen is important for everyone, including people of all skin colors. Consumers should continue to adopt sunscreen measures, including using SPF15 or higher broad-spectrum sunscreen products, so the update of the sunscreen product monograph is being promoted.

● Regulatory timeline

1. In 1972, an FDA drug review procedure was established for ingredients in 26 OTC treatment categories;

2. In 1978, the first proposed rules for the development of a sunscreen monograph were published;

3.In 1993, a specialized opinion draft was published;

4. In 1999, an official monograph on sunscreen products was released;

5. In 2001, the final monograph of 1999 was postponed;

6. In 2011, a special issue on sunscreen products related to labeling and SPF was published (21CFR sec 201.327);

7. In 2014, US President Obama signed the Sunscreen Innovation Act;

8. In 2016, OTC sun protection product safety and efficacy data guidelines were released;

9. In 2019, a proposed new provisional final monograph (TFM) and guidelines for maximum active ingredient usage exploratory testing (Must) were released;

10. In 2020, the COVID-19 Assistance, Relief and Economic Security Act (CARES Act), which aims to reform the FDA's OTC monograph process;

11. On September 24, 2021, the FDA issued the Final Administrative Order (DFO) for sunscreen products, which sets out the requirements for the current sale of OTC sunscreen products; Subsequently, a Proposed Order (PO) was issued, reflecting the FDA's proposed requirements for future over-the-counter sunscreen products.

● Comparison of Final Administrative Order (DFO) and Proposed Order (PO)

● Popularization of sunscreen knowledge

1. Broad spectrum sunscreen products help prevent two types of solar ultraviolet radiation, UVA and UVB. The SPF value of broad-spectrum sunscreen products is 15 or higher, and when used in conjunction with other sunscreen measures, it can reduce the risk of skin cancer and early skin aging.

2. There is no waterproof sunscreen product available

All sunscreen products, even those claiming to be "water resistant," will eventually be washed off. A 40 or 80 minute water resistance claim indicates how long consumers can receive SPF level protection on the label when entering or exiting water. Manufacturers cannot claim that their sunscreen is "waterproof" or "sweatproof".

3. Infants under 6 months old are not recommended to use sunscreen products

Babies are more susceptible to the side effects of sunscreen, such as rashes, than adults. The FDA recommends that babies stay away from the sun between 10am and 2pm, and if they must be in the sun, they should wear protective clothing. Wear lightweight pants, long sleeved shirts, and a brimmed hat covering the neck to protect the baby from sunburn. Before applying sunscreen products to children under 6 months old, please consult a doctor.

● FDA sunscreen product registration

The US Food and Drug Administration (FDA) lists sunscreen products as drugs. Sun protection product manufacturers must comply with all drug requirements, including cGMP (Current Good Manufacturing Practice), corporate registration, NDC label vendor code application, product listing, and labeling compliance.

Sun protection product manufacturers must update their business registration and product listing between October 1st and December 31st each year. Self owned brand distributors of sunscreen products must have their own NDC number and product listing.

Sunscreen products are included in the final FDA monograph list, so these products do not require FDA approval, but should comply with OTC monographs.

● Services ZOOP can provide

◆ Apply for a Dun & Bradstreet number (DUNS number)

◆ Business Registration

◆ US Agent + Business Registration (Suitable for factories without a US agent)

◆ NDC Label Code Application

◆ Product Listing

◆ Formula review

◆ Label and claim review

◆ Annual report service

◆ Product testing services

Cosmetics

Disinfection Products

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