HERA SILKYSTAY FOUNDATION 37W1 — Amorepacific Corporation drug label update
Amorepacific Corporation updated the drug labeling for HERA SILKYSTAY FOUNDATION 37W1, a cosmetic product containing sunscreen active ingredients. The update includes standardized indications for the prevention of sunburn and the reduction of skin cancer and premature skin aging risks.
Amorepacific Corporation, regulatory affairs professionals specializing in over-the-counter (OTC) drug-cosmetic combinations, and labeling compliance officers.
This update reflects standard compliance with OTC sunscreen monograph requirements. The inclusion of specific language regarding skin cancer and early skin aging suggests the product meets the broad-spectrum requirements necessary to make such claims. Failure to align labeling with these specific phrases can result in misbranding for products marketed as both foundation and sunscreen.
Regulatory teams should verify that all SPF-containing cosmetic labels include the mandatory risk reduction statements regarding skin cancer and early skin aging. Quality units should ensure that directions for use explicitly link to these broader sun protection measures as required by OTC monographs.
HERA SILKYSTAY FOUNDATION 37W1 (Amorepacific Corporation). Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin
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