COPPERTONE GLOW SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Coppertone Glow Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone Glow Sunscreen 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 INGREDIENT

Active ingredients

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%,

Octocrylene 9%

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 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

Directions

■ shake well before each use

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 40 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 SAFETY INFORMATION

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients water, SD alcohol 40-B, butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, glycerin, hydroxyacetophenone, mica, synthetic fluorphlogopite, tocopherol, ethylhexyl methoxycrylene, arachidyl alcohol, iron oxides, bismuth oxychloride, fragrance, xanthum gum, behenyl alcohol, silica, arachidyl glucoside, disodium EDTA, sodium ascorbyl phosphate

QUESTIONS

Questions? 1-866-288-3330

Coppertone Sunscreen Lotion Glow with Shimmer SPF 50 5 oz. tube

Coppertone®

SUNSCREEN LOTION

Glow

WITH SHIMMER 50 SPF

BROAD SPECTRUM SPF 50

Free from Parabens,

PABA, phthalates

AND oxybenzone

WATER RESISTANT (40 MINUTES)

5 FL OZ (148 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE GLOW SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.03 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90.09 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45.045 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80.08 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DOCOSANOL (UNII: 9G1OE216XY)
WATER (UNII: 059QF0KO0R)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISODODECANE (UNII: A8289P68Y2)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
GLYCERETH-26 (UNII: NNE56F2N14)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7444-1	148 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2019	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2019	08/01/2021

Labeler - Bayer HealthCare LLC. (112117283)