COPPERTONE ULTRA GUARD SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray

Coppertone Ultra Guard SPF 50 by

Drug Labeling and Warnings

Coppertone Ultra Guard SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

COPPERTONE ULTRA GUARD SPF 50 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7426
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	23.2 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	15.4 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	77.3 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	34.8 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	69.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (Clear to pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7426-1	45 g in 1 CAN; Type 0: Not a Combination Product	11/01/2017	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2017	09/01/2020

Labeler - Bayer HealthCare LLC. (112117283)