COPPERTONE PURE AND SIMPLE BABY SUNSCREEN SPF 50- zinc oxide 24.08% lotion 
Beiersdorf Inc

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Coppertone P&S Baby Lotion SPF 50

Drug Facts

Active ingredient

Zinc Oxide 24.08%

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

■ shake well before each 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, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, tocopherol, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, 1,2-hexanediol, caprylyl glycol

Questions?

1-866-288-3330

Coppertone

Zinc Oxide Sunscreen

Pure&Simple

#1 Pediatrician Recommended Sunscreen Brand

Baby

50

100% Mineral Sun Protection

Hypoallergenic & Tear Free Suitable for Sensitive Skin

Free of Oxybenzone, Octinoxate, PABA, Parabens, Dyes, Fragrance

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

PS Baby Lotion1

COPPERTONE PURE AND SIMPLE BABY SUNSCREEN SPF 50 
zinc oxide 24.08% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-2871
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.08 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PELARGONATE (UNII: 3YU1SQ04DV)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
POLYESTER-7 (UNII: 0841698D2F)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
Product Characteristics
Colorwhite (White to Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-2871-7177 g in 1 TUBE; Type 0: Not a Combination Product12/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/06/2023
Labeler - Beiersdorf Inc (001177906)

Revised: 11/2023
Document Id: 092b50bc-5f9f-80b0-e063-6394a90a4b95
Set id: 08134b95-1879-27e5-e063-6294a90a29af
Version: 2
Effective Time: 20231102
 
Beiersdorf Inc