COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion

Coppertone Protect and Tan Sunscreen SPF 45 by

Drug Labeling and Warnings

Coppertone Protect and Tan Sunscreen SPF 45 by is a Otc medication manufactured, distributed, or labeled by Beiersdort Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Use

■ helps prevent sunburn

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.

Stop use and ask a doctor if rash occurs

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

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

water, butyloctyl salicylate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, arachidyl alcohol, behenyl alcohol, dihydroxyacetone, acrylates/C12-22 alkyl methacrylate copolymer, 1,2-hexanediol, sodium stearoyl glutamate, arachidyl glucoside, erythrulose, hydroxyacetophenone, tocopherol, fragrance, pentylene glycol, caramel

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone® Sunscreen + Self Tanner

Glow

Protect & Tan 45

UVA/UVB Protection + Gradual Tanner

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 45

5 FL OZ (148 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45 
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-0079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
ALLYL METHACRYLATE (UNII: G2IG50653Z)
WATER (UNII: 059QF0KO0R)
L-ERYTHRULOSE (UNII: WKK1W5B83O)
DOCOSANOL (UNII: 9G1OE216XY)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white (White to Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-0079-1	148 g in 1 TUBE; Type 0: Not a Combination Product	11/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/03/2021

Labeler - Beiersdort Inc (001177906)