COPPERTONE GLOW SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

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

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
Bayer HealthCare LLC.
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:
11523-7443-1

COPPERTONE GLOW SUNSCREEN SPF 30- avobenzone, homosalate, octisalate,

octocrylene lotion

Bayer HealthCare LLC.

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.

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Coppertone Glotion SPF 30 UI 1613706

Drug Facts

Active ingredients

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

Octocrylene 8%

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

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 information

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients water, SD alcohol 40-B, diethylhexyl carbonate, butyloctyl salicylate, diisopropyl

adipate, glycereth-26, butylene glycol, dimethicone, polyamide-8, isododecane, styrene/acrylates

copolymer, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer,

glycerin, hydroxyacetophenone, mica, synthetic fluorphlogopite, tocopherol, ethylhexyl

methoxycrylene, arachidyl alcohol, iron oxides, bismuth oxychloride, fragrance, xanthan gum, behenyl

alcohol, silica, arachidyl glucoside, disodium EDTA, sodium ascorbyl phosphate

Questions? 1-866-288-3330

5 OZ. LABEL

Coppertone®

SUNSCREEN LOTION

Glow

WITH SHIMMER 30 SPF

BROAD SPECTRUM SPF 30

Free from Parabens,

PABA, phthalates

AND oxybenzone

WATER RESISTANT (40 MINUTES)

5 FL OZ (148 mL)

COPPERTONE GLOW SUNSCREEN SPF 30

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-7443

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

9 0 .0 9 mg in 1 mL

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

OCTOCRYLENE

8 0 .0 8 mg in 1 mL

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

AVOBENZONE

30 .0 3 mg in 1 mL

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

AVOBENZONE

30 .0 3 mg in 1 mL

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

OCTISALATE

45.0 45 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

STYRENE/ACRYLAMIDE CO PO LYMER ( MW 50 0 0 0 0 ) (UNII: 5Z4DPO246 A)

BRO WN IRO N O XIDE (UNII: 1N0 32N7MFO)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

DIISO PRO PYL ADIPATE (UNII: P7E6 YFV72X)

PO LYAMIDE-8 ( 4 50 0 MW) (UNII: 77723GV8 1A)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

XANTHAN GUM (UNII: TTV12P4NEE)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

DO CO SANO L (UNII: 9 G1OE216 XY)

GLYCERETH-2 6 (UNII: NNE56 F2N14)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

MICA (UNII: V8 A1AW0 8 8 0 )

DIETHYLHEXYL CARBO NATE (UNII: YCD50 O0 Z6 L)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

AMMO NIUM ACRYLO YLDIMETHYLTAURATE/BEHENETH-2 5 METHACRYLATE CRO SSPO LYMER ( 52 0 0 0

MPA.S) (UNII: LZ29 1VH9 0 H)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO XYACETO PHENO NE (UNII: G1L3HT4CMH)

ETHYLHEXYL METHO XYCRYLENE (UNII: S3KFG6 Q5X8 )

ARACHIDYL ALCO HO L (UNII: 1QR1QRA9 BU)

BISMUTH O XYCHLO RIDE (UNII: 4ZR79 2I58 7)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

ARACHIDYL GLUCO SIDE (UNII: 6 JVW35JOOJ)

Product Characteristics

Color

white (Off white to light yello w with shimmer)

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:11523-7443-1

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

0 2/0 1/20 19

0 8 /0 1/20 21

Marketing Information

Bayer HealthCare LLC.

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

0 2/0 1/20 19

0 8 /0 1/20 21

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 7/2019

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