COPPERTONE WATERBABIES PURE AND SIMPLE  SPF 50- octinoxate, octisalate and zinc oxide lotion 
MSD Consumer Care, 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® 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

Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

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)

Principal Display Panel - 237 mL Bottle Label
COPPERTONE WATERBABIES PURE AND SIMPLE   SPF 50
octinoxate, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7290
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (octinoxate) octinoxate85.2 mg  in 1 mL
octisalate (octisalate) octisalate56.8 mg  in 1 mL
zinc oxide (zinc oxide) zinc oxide164.72 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
propylene glycol 
Alkyl (C12-15) Benzoate 
neopentyl glycol diheptanoate 
cyclomethicone 5 
triethoxycaprylylsilane 
aloe vera leaf 
ethylhexyl palmitate 
diazolidinyl urea 
methylparaben 
propylparaben 
sodium chloride 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/21/1999
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 9/2012
 
MSD Consumer Care, Inc.