Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Ventura Corporation LTD
OCTINOXATE
OCTINOXATE 0.03 g in 1 g
TOPICAL
OTC DRUG
- Helps prevent sunburn
OTC monograph final
LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM PORCELAINE- BEIGE- OCTINOXATE, TITANIUM DIOXIDE, AND OXYBENZONE POWDER LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM TRANSLUCIDE- BEIGE- OCTINOXATE, TITANIUM DIOXIDE, AND OXYBENZONE POWDER LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM SANTE- BEIGE- OCTINOXATE, TITANIUM DIOXIDE, AND OXYBENZONE POWDER VENTURA CORPORATION LTD _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._ ---------- L'BEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE POWDER SPF 15 FM _DRUG FACTS_ _ACTIVE INGREDIENTS_ _PURPOSE_ TITANIUM DIOXIDE 3.54 % Sunscreen OCTINOXATE 3.00 % Sunscreen OXYBENZONE 3.00 % Sunscreen US ES 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 help prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damage 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 and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor. OTHER INFORMATION Protect the product in this container from excessive heat and direct sun. INACTIVE INGREDIENTS TALC, ZEA MAYS (CORN) STARCH, SILICA, CALCIUM CARBONATE, KAOLIN, ZINC STEARATE, OCTYLDODECANOL, ISOSTEARYL NEOPENTANOATE, GLYCERYL CAPRYLATE, METHYL METHACRYLATE CROSSPOLYMER, MAGNESIUM MYRISTATE, PHENOXYETHANOL, SODIUM POTASSIUM ALUMINUM SILICATE, HYDROGEN DIMETHICONE, TOCOPHERYL ACETATE, ALUMINA, CAPRYLYL GLYCOL, CHLORPHENESIN, MICROCRYSTALLINE WAX, PETROLATUM, PHOSPHOLIPIDS, CHOLESTE Read the complete document