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

Coppertone Pure and Simple Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone 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

Drug Facts

Active Ingredient

(To Deliver) Zinc Oxide 24.08%

Purpose

Sunscreen

Use

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

DO NOT USE

■ 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 methoxycrylene, polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, caprylyl methicone, sodium chloride, cetyl dimethicone

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone ® Sunscreen Spray

Pure&Simple

100% Mineral Sun Protection †

Free of oxybenzone, octinoxate, PABA, parabens, dyes, fragrance

Hypoallergenic

Naturally sourced zinc oxide

With nourishing botanicals*

Water Resistanct (80 minutes)

Broad Specturm SPF 50

NET WT 5 OZ (142 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4744
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	240.8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYESTER-7 (UNII: 0841698D2F)
ISOBUTANE (UNII: BXR49TP611)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-4744-5	142 g in 1 CAN; Type 0: Not a Combination Product	01/01/2021
2	NDC: 66800-4744-6	142 g in 1 CAN; Type 0: Not a Combination Product	01/01/2021
3	NDC: 66800-4744-7	142 g in 1 CAN; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

Labeler - Beiersdorf Inc (001177906)