COPPERTONE ULTRAGUARD SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Coppertone ultraGUARD by

Drug Labeling and Warnings

Coppertone ultraGUARD 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

Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 7%, Oxybenzone 4%

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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

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

• 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, sunglasses
• children under 6 months: Ask a doctor

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics or surfaces

Inactive Ingredients

Water, Sorbitol, Aluminum Starch Octenylsuccinate, VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol (Vitamin E), Polyglyceryl-3 Distearate, Fragrance, Methylparaben, Carbomer, Propylparaben, Disodium EDTA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

New Look

Coppertone®

SUNSCREEN LOTION

ULTRA

GUARD®

Intense

Defense

50

Protects Against

Damaging UVA/UVB Rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

COPPERTONE ULTRAGUARD  SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	133.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	72.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	41.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7206-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1999	09/01/2020
2	NDC: 11523-7206-2	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1999	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/21/1999	09/01/2020

Labeler - Bayer HealthCare LLC. (112117283)