COPPERTONE WATER BABIES STICK SPF 50- octinoxate, octocrylene, zinc oxide stick

Coppertone Water Babies by

Drug Labeling and Warnings

Coppertone Water Babies by is a Otc medication manufactured, distributed, or labeled by Bayer Healthcare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredients

Octinoxate 7.5%, Octocrylene 10%, Zinc Oxide 15%

PURPOSE

Sunscreen

Uses

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 cause by the sun

Warnings

For external use only.

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.

Stop use and ask a doctor

Stop use and 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

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 suncreen with a Broad Specturm SPF value of 15 or higher and other sun protection measures insluding:

• limit time in the sun, especially from 10 a.m.-2p.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

Caprylic/Capric Triglyceride, Ozokerite, Theobroma Cacao (cocoa) Seed Butter, Lauryl Laurate, Bis-PEG-12 Dimethicone Beeswax, C12-15 Alkyl Benzoate, Synthetic Beeswax

Questions?

1-866-288-3330

Package label

New Look

Coppertone®

SUNSCREEN STICK

water

babies®

Pure & Simple

50

Mineral-Based

Formula

Paraben and

PABA Free

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

#1

Pediatrician

Recommended

Brand

INGREDIENTS AND APPEARANCE

COPPERTONE WATER BABIES  STICK SPF 50
octinoxate, octocrylene, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LAURYL LAURATE (UNII: GPW77G0937)
BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7401-1	1 in 1 BLISTER PACK	11/30/2016	09/01/2021
1		13.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/30/2016	09/01/2021

Labeler - Bayer Healthcare LLC. (112117283)