COPPERTONE OIL FREE AND SHINE CONTROL FACE SUNSCREEN SPF 45- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion 
Beiersdorf Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Coppertone Oil Free + Shine Control 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

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), silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, cetyl alcohol, sodium ascorbyl phosphate

Questions?

1-866-288-3330

Coppertone ® Oil Free + Shine Control

Face

45

Blends Clear On All Skin Tones

Won't Clog Pores

Free of Oxybenzone, Octinoxate, PABA & Phthalates

Water Resistant (40 Minutes)

Broad Spectrum SPF 45

oil free shine control

COPPERTONE OIL FREE AND SHINE CONTROL FACE SUNSCREEN SPF 45 
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-8164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
POLYGLYCERYL-6 ISOSTEARATE (UNII: 5VKGO1O03G)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DOCOSANOL (UNII: 9G1OE216XY)  
Product Characteristics
Colorwhite ((White to Off-White)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-8164-274 g in 1 TUBE; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2023
Labeler - Beiersdorf Inc (001177906)

Revised: 2/2023
Document Id: f3d163b4-6775-4c2e-e053-2a95a90afd59
Set id: f3d163b4-6774-4c2e-e053-2a95a90afd59
Version: 1
Effective Time: 20230203
 
Beiersdorf Inc