COPPERTONE PROTECT AND TAN SPF 30- avobenzone 3%, homosalate 14%, octisalate 4.5%, octocrylene 9% lotion

Coppertone Protect and Tan SPF 30 by

Drug Labeling and Warnings

Coppertone Protect and Tan SPF 30 by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 14%, Octisalate 4.5%, Octocrylene 9%

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.

Directions

■ shake well before use

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 80 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 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, pentylene glycol, tocopherol, fragrance, caramel

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone® Sunscreen + Self Tanner

Glow

Protect & Tan 30

UVA/UVB Protection + Gradual Tanner

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 30

5 FL OZ (148 mL).

INGREDIENTS AND APPEARANCE

COPPERTONE PROTECT AND TAN SPF 30 
avobenzone 3%, homosalate 14%, octisalate 4.5%, octocrylene 9% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-0082
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 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	14 g  in 100 g

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

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: 66800-0082-1	148 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/02/2021

Labeler - Beiersdorf Inc (001177906)