COPPERTONE PURE AND SIMPLE BABY SUNSCREEN SPF 50- zinc oxide 24.08% aerosol, spray

Coppertone Pure and Simple Baby Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone Pure and Simple Baby 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 ingredient

Zinc Oxide (24.08%)

Purpose

Sunscreen

Uses

■ helps prevent sunburn

Warnings

For external use only
Flammable: Do not use near heat, flame, or while smoking

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product
■ keep away from face to avoid breathing it

■ keep out of eyes. Rinse with water to remove.

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

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

■ shake well before each use

■ spray liberally and spread evenly by hand 15 minutes before sun exposure

■ hold container 4 to 6 inches from the skin to apply

■ do not spray directly into face. Spray on hands then apply to face.

■ do not apply in windy conditions

■ use in a well-ventilated area

■ 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

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

isobutane, water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, cetyl dimethicone, triethoxycaprylylsilane, beeswax, tocopherol (vitamin E), hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, caprylyl methicone

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone

Zinc Oxide Sunscreen Spray

Pure&Simple

#1 Pediatrician Recommended Sunscreen Spray

Baby

50

100% Mineral Sun Protection

Hypoallergenic & Tear Free

Suitable for Sensitive Skin

Free of Oxybenzone, Octinoxate, PABA, Parabens, Dyes, Fragreance

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

COPPERTONE PURE AND SIMPLE BABY SUNSCREEN SPF 50 
zinc oxide 24.08% aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-2881
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.08 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
TOCOPHEROL (UNII: R0ZB2556P8)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYESTER-7 (UNII: 0841698D2F)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
ETHYLHEXYL PELARGONATE (UNII: 3YU1SQ04DV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-2881-5	142 g in 1 CAN; Type 0: Not a Combination Product	01/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/08/2024

Labeler - Beiersdorf Inc (001177906)