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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Available from:
Beiersdorf Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph not final
Authorization number:
66800-4480-4

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COPPERTONE GLOW HYDRAGEL SUNSCREEN SPF 30- avobenzone 3%, homosalate 10%,

octisalate 4.5%, octocrylene 9% gel

Beiersdorf Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Coppertone Glow Hydragel Sunscreen SPF 30

Drug Facts

Drug Facts

Active Ingredients

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 9%

Purpos e

Purpose

Sunscreen

Us es

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 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 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

Ques tions

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)

COPPERTONE GLOW HYDRAGEL SUNSCREEN SPF 30

avobenzone 3%, homosalate 10%, octisalate 4 .5%, octocrylene 9% gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 8 0 0 -448 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

10 0 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

45 mg in 1 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

9 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

O CTENYLSUCCINIC ACID (UNII: 12UZE4X73L)

MO DIFIED CO RN STARCH ( 1-O CTENYL SUCCINIC ANHYDRIDE) (UNII: 46 1P5CJN6 T)

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( HARD PARTICLE) (UNII: H8 9 5X0 8 VNQ)

PO LYESTER-7 (UNII: 0 8 416 9 8 D2F)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

ALUMINUM MAGNESIUM HYDRO XIDE CARBO NATE (UNII: RFJ7QXF345)

FRAGRANCE FRESH CITRUS FLO RAL O RC150 14 9 5 (UNII: OU4GI2R2WB)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

DICAPRYLYL ETHER (UNII: 77JZM5516 Z)

ETHYLHEXYL ISO NO NANO ATE (UNII: I6 KB4GE3K4)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

BUTYL ACRYLATE/C16 -C2 0 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE

CO PO LYMER (UNII: 7K6 8 DGG29 P)

Product Characteristics

Color

yello w (white to pale yello w)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 8 0 0 -448 0 -4

133 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

11/0 2/20 20

Beiersdorf Inc

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

11/0 2/20 20

Labeler -

Beiersdorf Inc (001177906)

Revised: 12/2020

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