Country: United States
Language: English
Source: NLM (National Library of Medicine)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Supergoop, LLC
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
SUNNYSCREEN SPF 50- TITANIUM DIOXIDE, ZINC OXIDE SPRAY SUPERGOOP, LLC _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._ ---------- SUNNYSCREEN SPF 50 SPRAY FOR BABIES + KIDDOS _ACTIVE INGREDIENT PURPOSE_ Titanium Dioxide 10% Sunscreen Zinc Oxide 12% Sunscreen _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. 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 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 value of 15 or higher and other sun protection measures including: • limit your time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: ask a doctor. _INACTIVE INGREDIENTS_ Aqua (Deionized water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Read the complete document