COPPERTONE WATERBABIES PURE AND SIMPLE MINERAL SPF 50- octinoxate, octisalate, zinc oxide lotion

Coppertone Waterbabies Pure and Simple Mineral SPF 50 by

Drug Labeling and Warnings

Coppertone Waterbabies Pure and Simple Mineral SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bayer Healthcare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

COPPERTONE WATERBABIES PURE AND SIMPLE MINERAL SPF 50 
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7377
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	56.8 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	85.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	164.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (off white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7377-1	59 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2017	09/01/2021
2	NDC: 11523-7377-2	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2017	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2017	09/01/2021

Labeler - Bayer Healthcare LLC. (112117283)