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

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Coppertone Complete Face Lotion SPF 45

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 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

■ 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

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

Complete Face 45

COPPERTONE COMPLETE SUNSCREEN SPF 45 
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-8159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite ((white to off-white)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-8159-274 g in 1 TUBE; Type 0: Not a Combination Product01/01/2023
2NDC:66800-8159-514 g in 1 POUCH; Type 0: Not a Combination Product02/10/2023
3NDC:66800-8159-144 g in 1 TUBE; Type 0: Not a Combination Product01/05/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2023
Labeler - Beiersdorf Inc (001177906)

Revised: 2/2024
Document Id: 116f484f-8670-4840-e063-6394a90a11e9
Set id: f2a06097-b066-8631-e053-2a95a90a9ffc
Version: 7
Effective Time: 20240215
 
Beiersdorf Inc