Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Prime Enterprises, Inc.
TOPICAL
OTC DRUG
Sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
OTC monograph final
AUSTRALIAN GOLD BROAD SPECTRUM SPF 50- TITANIUM DIOXIDE AND ZINC OXIDE LOTION PRIME ENTERPRISES, INC. _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._ ---------- ACTIVE INGREDIENTS Titanium Dioxide 4.5 %, and Zinc Oxide 4 % PURPOS E Sunscreen US ES helps prevent sunburn if used as directed with other sun protection 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. Rinse 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 80 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/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutly Adipate, Dimethicone, Fragrance (Parfum), Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Trimethylsiloxysilicate, Water (Aqua), Xanthan Gum, may contain Citric Acid, may contain Sodium Hydroxide OTHER INFORM Read the complete document