COPPERTONE WATERBABIES PURE AND SIMPLE SPF 50- octinoxate, octisalate, and zinc oxide lotion 
Bayer Healthcare LLC.

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® waterBABIES® Pure & Simple SPF 50

Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide14.5 %

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 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, propylene glycol, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf extract, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Coppertone®

SUNSCREEN LOTION

with zinc oxide

water

BABIES®

Pure &

Simple

Broad

Spectrum

SPF

50

TEAR FREE

#1 Pediatrician

Recommended

Brand

Water Resistant

(80 minutes)

50

8 FL OZ (237 mL)

8 oz. lotion body

COPPERTONE WATERBABIES PURE AND SIMPLE  SPF 50
octinoxate, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE164.72 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE85.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE56.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7290-1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/199908/01/2019
2NDC:11523-7290-259 mL in 1 TUBE; Type 0: Not a Combination Product05/21/199908/01/2019
3NDC:11523-7290-3177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/199908/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/199908/01/2019
Labeler - Bayer Healthcare LLC. (112117283)

Revised: 8/2019
Document Id: 900536a9-b1c5-1c3e-e053-2995a90a3906
Set id: ff187b56-b392-40a7-9135-4e37203f9e71
Version: 7
Effective Time: 20190813
 
Bayer Healthcare LLC.