COPPERTONE PURE AND SIMPLE SUNSCREEN SPF 50- zinc oxide 24.08% 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 Pure & Simple Lotion SPF 50

Drug Facts

Active ingredients

Zinc Oxide 24.08%

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

■ 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

Questions?

1-866-288-3330

Coppertone ® Sunscreen Lotion

Pure & Simple

100% Mineral Sun Protection

50

Free Of oxybenzone, octinoxate, PABA, parabens, dyes, fragrance

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

P and S Kids resizedP and S Resized

P and S Baby resized

COPPERTONE PURE AND SIMPLE SUNSCREEN SPF 50 
zinc oxide 24.08% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-3993
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
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
TEA LEAF (UNII: GH42T47V24)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYESTER-7 (UNII: 0841698D2F)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)  
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-3993-259 g in 1 TUBE; Type 0: Not a Combination Product11/03/2020
2NDC:66800-3993-6177 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/2020
3NDC:66800-3993-7177 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/2020
4NDC:66800-3993-159 g in 1 TUBE; Type 0: Not a Combination Product11/03/2020
5NDC:66800-3993-5177 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/03/2020
Labeler - Beiersdorf Inc (001177906)

Revised: 3/2023
Document Id: f6527a03-41ea-5990-e053-2995a90a4973
Set id: d8d80a15-8282-a18e-e053-2a95a90a2c6c
Version: 5
Effective Time: 20230307
 
Beiersdorf Inc