COPPERTONE ULTRA GUARD SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray 
Bayer HealthCare LLC.

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 Ultra Guard Spray SPF 50 (Aerosol)

Drug Facts

Active ingredients

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,

Octocrylene 9%, Oxybenzone 2%

Purpose

Purpose

Sunscreen

Uses

Uses

■ helps prevent sunburn

Warnings

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 this product

When using this product
■ 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

Directions

■ shake well before use

■ apply liberally 15 minutes before sun exposure and rub into skin

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

■ use in well-ventilated areas

■ 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 SD alcohol 40-B (50.3% v/v), isobutane, isohexadecane, isododecane, dimethicone, VA/butyl maleate/isobornyl acrylate copolymer, C13-15 alkane, tocopherol (vitamin E), fragrance

Questions

Questions? 1-866-288-3330

Package display label

Coppertone®

Sunscreen Spray

ULTRA

GUARD®

INTENSE

DEFENSE 50

Protests Against

Damaging UVA/UVB Rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Product label

COPPERTONE ULTRA GUARD SPF 50 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7426
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE23.2 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE15.4 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE77.3 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE34.8 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE69.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ISOBUTANE (UNII: BXR49TP611)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ISODODECANE (UNII: A8289P68Y2)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
Product Characteristics
Coloryellow (Clear to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7426-145 g in 1 CAN; Type 0: Not a Combination Product11/01/201709/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201709/01/2020
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2019
 
Bayer HealthCare LLC.