Label: GLOW SCREEN SPF 40- avobenzone, octisalate, octocylene cream
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NDC Code(s):
75936-216-01,
75936-216-02,
75936-216-03,
75936-216-04, view more75936-216-05, 75936-216-06, 75936-216-07
- 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 July 10, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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 a Broad Spectrum SPF value of 15 or higher and other sun protection 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
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INACTIVE INGREDIENT
Inactive Ingredients
Water, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GLOW SCREEN SPF 40
avobenzone, octisalate, octocylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LAURYL LACTATE (UNII: G5SU0BFK7O) ISODODECANE (UNII: A8289P68Y2) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) CETYL PHOSPHATE (UNII: VT07D6X67O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE (UNII: 4828G836N6) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARGININE (UNII: 94ZLA3W45F) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) FERRIC OXIDE RED (UNII: 1K09F3G675) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CHLORPHENESIN (UNII: I670DAL4SZ) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) COCOA (UNII: D9108TZ9KG) PANTOTHENIC ACID (UNII: 19F5HK2737) TOCOPHEROL (UNII: R0ZB2556P8) SUNFLOWER OIL (UNII: 3W1JG795YI) FERULIC ACID (UNII: AVM951ZWST) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-216-01 1.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 2 NDC:75936-216-02 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 3 NDC:75936-216-03 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 4 NDC:75936-216-04 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 5 NDC:75936-216-05 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 6 NDC:75936-216-06 20 mL in 1 TUBE; Type 0: Not a Combination Product 05/18/2021 7 NDC:75936-216-07 73.9 mL in 1 TUBE; Type 0: Not a Combination Product 01/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2020 Labeler - Supergoop, LLC (117061743) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc 052400223 manufacture(75936-216)