Coppertone Waterbabies Pure & Simple Mineral Lotion SPF 50

Coppertone Waterbabies Pure & Simple Mineral Lotion SPF 50

Drug Labeling and Warnings

Drug Details

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COPPERTONE WATERBABIES PURE AND SIMPLE MINERAL SPF 50- octinoxate, octisalate, 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 Mineral Lotion SPF 50

Drug Facts

Inactive ingredients

Active ingredients

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

Purpose

Purpose

Sunscreen

Uses

Uses

■ helps prevent sunburn

Warnings

Warnings
For external use only

Do not use

Do not use on damaged or broken skin

When using this product

When using this product keep out of eyes. Rinse with water to remove.

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Stop useand ask a doctor if rash occurs.

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Ohter information

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

Inactive ingredientswater, 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?

Questions?1-866-288-3330

Package display 2 oz.

Product lable 2 oz.

COPPERTONE WATERBABIES PURE AND SIMPLE MINERAL SPF 50 
octinoxate, octisalate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7377
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE56.8 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE85.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE164.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorwhite (off white to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7377-159 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2017
2NDC: 11523-7377-2177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2017
Labeler - Bayer Healthcare LLC. (112117283)

Revised: 1/2018
 
Bayer Healthcare LLC.


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