Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
SolSkyn Personal Care LLC
TOPICAL
OTC DRUG
Sunscreen - helps prevent sunburn
OTC monograph not final
NO-AD SPF 8 TANNING- OCTINOXATE, OCTISALATE LOTION SOLSKYN PERSONAL CARE LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- NO-AD SPF 8 SUNSCREEN LOTION No Ad SPF8 Sunscreen Lotion _ACTIVE INGREDIENTS_ Octinoxate 4.5%, Octisalate 5% _PURPOSE_ Sunscreen _USES_ helps prevent sunburn _WARNINGS_ SKIN CANCER/SKIN AGING ALERT: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. FOR EXTERNAL USE ONLY DO NOT USE on damaged or broken skin WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove. STOP USE AND ASK A DOCTOR if rash occurs KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ apply liberally 15 minutes before sun exposure reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor _INACTIVE INGREDIENTS_ Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Carbomer, C12-15 Alkyl Benzoate, Daucus Carota Sativa (Carrot) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl-glycerin, Fragrance, Glycerin, Glycine Soja (Soybean) Oil, Hydroxypropyl Methylcellulose, Phenoxyethanol, Propylene Glycol, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water _OTHER INFORMATION_ for use on skin only. Avoid c Read the complete document