COPPERTONE LIMITED EDITION SUNSCREEN SPF 50- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% 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 Limited Edition Spray SPF 50

Drug Facts

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

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
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

■ 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

SD alcohol 40-B (73.8% v/v), isobutane, neopentyl glycol dipheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions?

1-866-288-3330

Limited Edition

Coppertone ® Sunscreen Spray 50

Protects against damaging UVA/UVB rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 1.6 OZ (45 g)

LE Spray SPF 50

COPPERTONE LIMITED EDITION SUNSCREEN SPF 50 
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4354
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
ALCOHOL (UNII: 3K9958V90M)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
POLYESTER-7 (UNII: 0841698D2F)  
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ISOBUTANE (UNII: BXR49TP611)  
Product Characteristics
Colorwhite (White to Pale Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-4354-145 g in 1 CAN; Type 0: Not a Combination Product11/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/04/2020
Labeler - Beiersdorf Inc (001177906)

Revised: 2/2023
Document Id: f4ead6c1-c174-7720-e053-2a95a90a5283
Set id: ccbf7795-e153-1a43-e053-2a95a90ad4b6
Version: 3
Effective Time: 20230217
 
Beiersdorf Inc