Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
TAYLOR JAMES, LTD.
TOPICAL
OTC DRUG
Uses - 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. Stop use and ask a doctor if rash occurs
OTC monograph final
INVINCIBLE SETTING POWDER SPF 45 MEDIUM- ZINC OXIDE POWDER TAYLOR JAMES, 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._ ---------- INVINCIBLE SETTING POWDER SPF 45 MEDIUM ACTIVE INGREDIENTS PURPOSE Zinc Oxide 24.5% 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. KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if rash occurs _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. Directions apply generously and evenly 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 value of 15 or higher and other sun protections measures including: Limit time in the sun, especially from 10a.m. -2p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor _INACTIVE INGREDIENTS_ Calcium Aluminum Borosilicate, Silica, Polymethyl Methacrylate, Ethylhexylglycerin, Triethoxycaprylysilane, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3. May contain +/- Iron Oxides (CI 77492, CI 77491, CI 77499), Titanium Dioxide (CI 77891) Invincible Setting Powder SPF 45 100% Mineral + Sweat resistant Medium 0.15 oz./ 4.25 g INVINCIBLE SETTING POWDER SPF 45 MEDIUM zinc oxide powder PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:759 36 -147 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BA Read the complete document