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

Glowscreen SPF 40 - Dawn by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3%.......................................Sunscreen

Homosalate 4%.......................................Sunscreen

Octisalate 5%.......................................Sunscreen

Octocrylene 8%.......................................Sunscreen

PURPOSE

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.

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

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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Water, Butyloctyl Salicylate, Propanediol, Titanium Dioxide, Glycerin, C12-15 Alkyl Benzoate, Mica, Glyceryl Stearate Citrate, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco-Caprylate, Arginine, Silica, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tin Oxide, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Iron Oxides, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Triethoxycaprylylsilane, Ferulic Acid

PRINCIPAL DISPLAY PANEL

SPF 40

Dawn
Broad Spectrum Sunscreen SPF 40 PA+++

1.7 fl. oz. / 50 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-606
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BROWN IRON OXIDE (UNII: 1N032N7MFO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
LIMONIUM GERBERI FLOWERING TOP (UNII: V4O4C05BJ2)
WATER O-18 (UNII: 7QV8F8BYNJ)
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE (UNII: 4828G836N6)
PANTOTHENIC ACID (UNII: 19F5HK2737)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERULIC ACID (UNII: AVM951ZWST)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
STANNIC OXIDE (UNII: KM7N50LOS6)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)
LAURYL LACTATE (UNII: G5SU0BFK7O)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GR-270773 PHOSPHOLIPID EMULSION (UNII: D4B2F53PBH)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PHOSPHATE (UNII: VT07D6X67O)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MICA (UNII: V8A1AW0880)
ARGININE (UNII: 94ZLA3W45F)
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-606-02	1 in 1 CARTON	03/17/2023
1	NDC: 75936-606-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75936-606-03	10 mL in 1 TUBE; Type 0: Not a Combination Product	03/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	03/15/2023

Labeler - Supergoop, LLC (117061743)