GLOW SCREEN BODY BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, homosalate, octisalate, octocrylene cream

Glow Screen Body Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

Glow Screen Body Broad Spectrum Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Homosalate 7%.............Sunscreen

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

Octocrylene 10%............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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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

• apply generously and evenly 15 minutes before sun exposure
• reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meausres including: Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglassess. Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

Aletris Farinosa Root Extract, Bisabolol, Butyloctyl Salicylate,Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryly Glycol, Cetearyl Alcohol, Coco-Caprylate/Caprate, Coco-Glucoside, Coconut Alkanes, Erythritol, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Glycerin, Glyceryl Stearate, Hydrogenated Polycyclopentadiene, Methyl Dlhydroabietate, Mica, Polyester-8, Propanedlol, Sodium Gluconate, Sodium Polyacrylate Starch, Sodium Stearoyl Glutamate, Titanium Dioxide, Tocopherol, Water, Xanthan Gum

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

Supergoop!

Glow Screen Body

SPF 40

Broad Spectrum Sunscreen

SPF 40 PA+++

Water & Sweat Resistant (40 minutes)

3.4 fl. oz. / 100 ml.

INGREDIENTS AND APPEARANCE

GLOW SCREEN BODY BROAD SPECTRUM SUNSCREEN SPF 40 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
ERYTHRITOL (UNII: RA96B954X6)
ETHYL FERULATE (UNII: 5B8915UELW)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALETRIS FARINOSA ROOT (UNII: O021JGR97X)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ALKANES (UNII: 1E5KJY107T)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICA (UNII: V8A1AW0880)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-350-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2021
2	NDC: 75936-350-02	10 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2021
3	NDC: 75936-350-03	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/20/2021

Labeler - Supergoop, LLC (117061743)