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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Coppertone Pure & Simple Spray SPF 50
Coppertone Pure & Simple Kids Spray SPF 50
Coppertone Pure & Simple Baby Sprays SPF 50

Drug Facts

Drug Facts

Active Ingredient

Active ingredients

(To Deliver) Zinc Oxide 24.08%

Purpose

Purpose

Sunscreen

Use

Use

helps prevent sunburn

Warnings

Warnings


For external use only


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


Do not use on damaged or broken skin


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 and ask a doctor if rash occurs

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 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

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

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

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)

P&S Spray SPF 50P&S Kid's Spray SPF 50P&S Baby Spray SPF 50

COPPERTONE PURE AND SIMPLE SUNSCREEN SPF 50 
zinc oxide 24.08% aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4744
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE240.8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-4744-5142 g in 1 CAN; Type 0: Not a Combination Product01/01/2021
2NDC:66800-4744-6142 g in 1 CAN; Type 0: Not a Combination Product01/01/2021
3NDC:66800-4744-7142 g in 1 CAN; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2021
Labeler - Beiersdorf Inc (001177906)

Revised: 2/2023
Document Id: f4d2e84b-f7b3-3fbf-e053-2a95a90a04e7
Set id: b6492438-5dd2-030e-e053-2a95a90a2f9f
Version: 2
Effective Time: 20230216
 
Beiersdorf Inc