Country: United States
Language: English
Source: NLM (National Library of Medicine)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
Anna Lotan Ltd
TOPICAL
OTC DRUG
Sunscreen • Helps to prevent sunburn • If used as directed with other sun protective measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
OTC monograph final
ANNA LOTAN PREMIUM BB CREAM SPF46 PALE BEIGE- TITANIUM DIOXIDE, OCTINOXATE CREAM ANNA LOTAN 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._ ---------- ANNA LOTAN PREMIUM BB CREAM SPF46 PALE BEIGE _DRUG FACTS_ _ACTIVE INGREDIENTS_ Titanium Dioxide 16% Octinoxate 6.99% _PURPOSE:_ Sunscreen _USES_ • Helps to prevent sunburn • If used as directed with other sun protective measures (see _DIRECTIONS_), decreases the risk of skin cancer and early skin aging caused by the sun. _WARNINGS_ FOR EXTERNAL USE ONLY • DO NOT USE on damaged or broken skin. WHEN USING THIS PRODUCT keep out of eyes. If contact occurs rinse thoroughly with water to remove. STOP USE AND ASK A DOCTOR if rash occurs. KEEP OUT OF REACH OF CHILDREN. If product is 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 protection measures including: • Limit time in sun from 10 a.m.- 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses. • Children under 6 months: Ask a doctor. _INACTIVE INGREDIENTS_ Water, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Cyclopentasiloxane, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Cyclohexasiloxane, Cetearyl Ethylhexanoate, Methyl Methacrylate Crosspolymer, Dipalmitoyl Hydroxyproline, Myristyl Myristate, Phenoxyethanol, Stearalkonium Hectorite, Microcrystalline Wax, Sodium Chloride, Paraffin, Polysilicone-11, Propylene Carbonate, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, BHT, Iron Oxides (CI Read the complete document