COPPERTONE GLOW HYDRAGEL SUNSCREEN SPF 30- avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 9% gel

Coppertone Glow Hydragel Sunscreen SPF 30 by

Drug Labeling and Warnings

Coppertone Glow Hydragel Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredients

Active Ingredients

Avobenzone 3%, Homosalate 10%, 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

Flammable. Keep away from fire or flame.

DO NOT USE

Do not use on damaged or broken skin

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.

WHEN USING

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

Directions

Directions

■ shake well before each use

■ 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 SD alcohol 40-B (60.2% v/v), dicaprylyl ether, ethylhexyl isononanoate, PVP, dimethicone/vinyl dimethicone crosspolymer, polyester-27, silica dimethicone silylate, beeswax, acrylates/C12-22 alkyl methacrylate copolymer, fragrance, silica, synthetic fluorphlogopite, iron oxides

Questions

Questions? 1-866-288-3330

Principal Display Panel

Principal Display Panel

Coppertone Sunscreen Gel

Glow Hydragel

SPF 30

Shimmery, Cool & Hydrating

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

Free of oxybenzone, octinoxate, PABA & parabens

4.5 FL OZ (133 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE GLOW HYDRAGEL SUNSCREEN SPF 30 
avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 9% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4480
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
POLYESTER-7 (UNII: 0841698D2F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
ALUMINUM MAGNESIUM HYDROXIDE CARBONATE (UNII: RFJ7QXF345)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)

Product Characteristics
Color	yellow (white to pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-4480-4	133 mL in 1 TUBE; Type 0: Not a Combination Product	11/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/02/2020

Labeler - Beiersdorf Inc (001177906)