Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Autumn Harp, Inc
ZINC OXIDE
ZINC OXIDE 3.2 mg in 100 mL
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
YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM- ZINC OXIDE, TITANIUM DIOXIDE CREAM AUTUMN HARP, 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._ ---------- YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM DRUG FACTS ACTIVE INGREDIENTS: Zinc Oxide (3.2%) Titanium Dioxide (2.9%) 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 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. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months: Ask a doctor. SUN PROTECTION MEASURE Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sun-glasses. INACTIVE INGREDIENTS Water, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Magnesium Aluminum Silicate, Propanediol, Coco-Glucoside, Zea Mays (Corn) Starch*, Citrus Grandis (Grapefruit) Peel Extract*, Moringa oleifera seed oil, Evodia Rutaecarpa Fruit Extract, Phenethyl Alcohol, Cetyl Alcohol, Fragrance, Glyceryl Caprylate, Xanthan Gum, Glyceryl Isostearate, Hydrated Silica, Glycine Soja (Soybean) Oil, Tocopherol, Cyamopsis Tetragonoloba ( Read the complete document