GLOW SCREEN SPF 40- avobenzone, octisalate, octocylene cream

Glow Screen SPF 40 by

Drug Labeling and Warnings

Glow Screen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Cosway Company, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients  Purpose
Avobenzone      3% Sunscreen
Octisalate         5% Sunscreen
Octocylene        10% Sunscreen

PURPOSE

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

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

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

Supergoop!

Glowscreen

SPF 40

Broad Spectrum Sunscreen

SPF 40 PA+++

1.7 fl. oz./ 50 ml.

INGREDIENTS AND APPEARANCE

GLOW SCREEN SPF 40 
avobenzone, octisalate, octocylene cream

Product 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2020

Labeler - Taylor James Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company, Inc.		620899877	manufacture(75936-216)