Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)
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
GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE OIL 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._ ---------- GLOW OIL BROAD SPECTRUM SPF 50 ACTIVE INGREDIENTS PURPOSE Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% 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 DO NOT USE ON damaged or broken skin WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove FOR EXTERNAL USE ONLY DIRECTIONS Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours. after 80 minutes if swimming or sweating 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. Caprylic/Capric Triglyceride, Alcohol, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester- 8, Polyamide-3, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexylsyringylidenemalonate, Tocopherol, Glycine Soja (Soybean)Oil, Vitis Vinifera (grape) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Limnanthes Alba(Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Pentaerythrityl Tetra-di- t-butyl hydroxyhydroc Read the complete document