COPPERTONE COMPLETE SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% 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.

----------

Coppertone Complete Lotion SPF 50

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Uses

■ helps prevent sunburn

■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 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, SD alcohol 40-B, butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, glycerin, hydroxyacetophenone, tocopherol, ethylhexyl methoxycrylene, arachidyl alcohol, fragrance, xanthan gum, behenyl alcohol, arachidyl glucoside, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

Coppertone® Sunscreen Lotion

Complete 50

Proven UVA/UVB Protection

+ Moisturizes All Day*

+ Feels Lightweight

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Complete Lotion SPF50

COPPERTONE COMPLETE SUNSCREEN SPF 50 
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DOCOSANOL (UNII: 9G1OE216XY)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERETH-26 (UNII: NNE56F2N14)  
ALCOHOL (UNII: 3K9958V90M)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
WATER (UNII: 059QF0KO0R)  
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-0030-7207 g in 1 TUBE; Type 0: Not a Combination Product11/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/02/2021
Labeler - Beiersdorf Inc (001177906)

Revised: 3/2023
Document Id: f6290f53-490f-ce93-e053-2a95a90aa1cb
Set id: d473e7ed-4a9f-76fe-e053-2995a90ab37d
Version: 2
Effective Time: 20230305
 
Beiersdorf Inc