COPPERTONE COMPLETE SUNSCREEN SPF 45- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion

Coppertone Complete Sunscreen SPF 45 by

Drug Labeling and Warnings

Coppertone Complete Sunscreen SPF 45 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 10%, 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:

■ 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 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

Questions?

1-866-288-3330

Inactive ingredients

water, alcohol denat., butyloctyl salicylate, silica, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, tapioca starch, behenyl alcohol, butylene glycol dicaprylate/dicaprate, C12-15 alkyl benzoate, cetearyl alcohol, copernicia cerifera (carnauba) wax, dibutyl adipate, tocopherol (Vitamin E), sodium ascorbyl phosphate, silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, sodium hyaluronate, cetyl alcohol

PRINCIPAL DISPLAY PANEL

Coppertone® Sunscreen Lotion

Complete Face 45

Proven UVA/UVB Protection

+Hydrates

+Weightless & Oil Free

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (40 Minutes)

Broad Spectrum SPF 45

INGREDIENTS AND APPEARANCE

COPPERTONE COMPLETE SUNSCREEN SPF 45 
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-8159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
TOCOPHEROL (UNII: R0ZB2556P8)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STARCH, TAPIOCA (UNII: 24SC3U704I)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DOCOSANOL (UNII: 9G1OE216XY)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)

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: 66800-8159-2	74 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2023
2	NDC: 66800-8159-5	14 g in 1 POUCH; Type 0: Not a Combination Product	02/10/2023
3	NDC: 66800-8159-1	44 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023

Labeler - Beiersdorf Inc (001177906)