COPPERTONE ULTRA GUARD SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Coppertone Ultra Guard by

Drug Labeling and Warnings

Coppertone Ultra Guard 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

Avobenzone 3%, Homosalate 15%, Octisalate 5%,

Octocrylene 10%, Oxybenzone 6%

Purpose

Purpose

Sunscreen

Uses

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

Warnings
For external use only

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.

Stop use and ask a doctor if

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

■ apply liberally 15 minutes before sun exposure

■ 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

■ may stain or damage some fabrics or surfaces

Inactive ingredients

Inactive ingredients water, butylene glycol, microcrystalline cellulose, glyceryl stearate, behenyl alcohol, benzyl alcohol, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate, stearic acid, palmitic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, lecithin, caprylic/capric triglyceride, chlorphenesin, cellulose gum, butylated PVP, disodium EDTA

Questions

Questions? 1-866-288-3330

Package display panel 8 oz.

New Look

Coppertone®

SUNSCREEN LOTION

ULTRA

GUARD®

Intense

Defense 70

Protects Against

Damaging UVA/UVB Rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 70

INGREDIENTS AND APPEARANCE

COPPERTONE ULTRA GUARD  SPF 70 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	153.15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.05 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	102.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	61.26 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURYL ALCOHOL (UNII: 178A96NLP2)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Product Characteristics
Color	white (off-White to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7436-1	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1999	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/21/1999	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)