COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

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 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, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice,

tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide,

disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone ® Sunscreen Lotion

Waterbabies Light Lotion

SPF50

Formulated with Vitamin E

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50 
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4839
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	white (White to Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-4839-6	177 g in 1 TUBE; Type 0: Not a Combination Product	12/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2021

Labeler - Beiersdorf Inc (001177906)