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

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

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.

Directions

■ apply liberally 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-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

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)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

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 Drug	M020	11/03/2021

Labeler - Beiersdort Inc (001177906)