GLOWSCREEN SPF 40 -SUNSET- avobenzone, homosalate, octisalate, octocrylene lotion

Glowscreen SPF 40 -Sunset by

Drug Labeling and Warnings

Glowscreen SPF 40 -Sunset by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Avobenzone 3%, Homosalate 4%, Octisalate 5%, Octocrylene 8%

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

WARNINGS

For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes Rinse with water to remove

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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

Protect the product in this container from excessive heat and direct sun

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

Supergoop!

Glow Screen SPF 40

Sunset

1.7 fl. oz./ 50 mL

INGREDIENTS AND APPEARANCE

GLOWSCREEN SPF 40 -SUNSET 
avobenzone, homosalate, octisalate, octocrylene lotion

Product 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)