Label: GLOWSCREEN SPF 40 -SUNSET- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 75936-608-01, 75936-608-02
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 27, 2023
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- Official Label (Printer Friendly)
- Active Ingredients:
- Uses:
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions:
apply generously and evenly 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen 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 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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Water, Butyloctyl Salicylate, Propanediol, Glycerin, C12-15 Alkyl Benzoate, Iron Oxides, Glyceryl Stearate Citrate, Mica, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco-Caprylate, Arginine, Titanium Dioxide, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Bismuth Oxychloride, Sodium Hyaluronate, Chlorphenesin, Ethylhexyl Hydroxystearate, Trisodium Ethylenediamine Disuccinate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Stearoyl Glutamate, Arachidyl Alcohol, Phospholipids, Behenyl Alcohol, Limonium Gerberi Extract, Arachidyl Glucoside, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Triethoxycaprylylsilane, Pantothenic Acid, Tocopherol, Ferulic Acid, Helianthus Annuus (Sunflower) Seed Oil
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GLOWSCREEN SPF 40 -SUNSET
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PROPANEDIOL (UNII: 5965N8W85T) LAURYL LACTATE (UNII: G5SU0BFK7O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL PHOSPHATE (UNII: VT07D6X67O) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) FERULIC ACID (UNII: AVM951ZWST) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISODODECANE (UNII: A8289P68Y2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE (UNII: 4828G836N6) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) LIMONIUM PLATYPHYLLUM WHOLE (UNII: 2J5K7YCF9F) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) COCOA (UNII: D9108TZ9KG) SUNFLOWER OIL (UNII: 3W1JG795YI) ARGININE (UNII: 94ZLA3W45F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PANTOTHENIC ACID (UNII: 19F5HK2737) TOCOPHEROL (UNII: R0ZB2556P8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) BROWN IRON OXIDE (UNII: 1N032N7MFO) WATER O-18 (UNII: 7QV8F8BYNJ) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) MICA (UNII: V8A1AW0880) NIACINAMIDE (UNII: 25X51I8RD4) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-608-01 1 in 1 CARTON 03/01/2023 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:75936-608-02 10 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 03/01/2023 Labeler - Supergoop, LLC (117061743)
