FDA.reportPublic FDA data

Coppertone Glow Hydragel SPF 50

Manufacturer
Beiersdort Inc
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:30:31

Label at a glance#

ProductCoppertone Glow Hydragel SPF 50
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE, OCTISALATE
Label structure14 sections

Indications and 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

Dosage and administration

■ 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 protect...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

  • For external use only
  • Flammable.Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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 SAFETY INFORMATION

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

SD alcohol 40-B (57.4% v/v), butyloctyl salicylate, dicaprylyl ether, ethylhexyl isononanoate, PVP, dimethicone/vinyl dimethicone crosspolymer, polyester-27, silica dimethicone silylate, acrylates/C12-22 alkyl methacrylate copolymer, calcium starch octenylsuccinate, fragrance, silica, synthetic fluorphlogopite, iron oxides

Questions?

OTC - QUESTIONS SECTION

1-866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coppertone Sunscreen Gel

Glow Hydragel

SPF 50

Shimmery, Cool & Hydrating

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Free of oxybenzone, octinoxate, PABA & parabens

4.5 FL OZ (133 mL)

GlowGlow

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041100586636GTIN-13: 0041100586636
EAN-13: 0041100586636
GTIN-12: 041100586636
UPC-A: 041100586636
GTIN storage (14 digits): 00041100586636		Glow Hydragel_SPF50_4.5 fl oz_C00010218.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-4473-4Coppertone Glow Hydragel SPF 50133 mL in 1 TUBEGEL1339

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66800-447366800-4473-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICAPRYLYL ETHER77JZM5516ZIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
STARCH, CORNO8232NY3SJIACT
ALUMINUM MAGNESIUM HYDROXIDE CARBONATERFJ7QXF345IACT
POLYESTER-70841698D2FIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
FRAGRANCE FRESH CITRUS FLORAL ORC1501495OU4GI2R2WBIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
FERRIC OXIDE RED1K09F3G675IACT
ALCOHOL3K9958V90MIACT
OCTENYLSUCCINIC ACID12UZE4X73LIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
ndc (package): 66800-4473-4
ndc (product): 66800-4473
ndc11 (package): 66800447304
spl id: 4746a77b-7b41-ffd5-e063-6294a90af0c1
spl set id: b5f7cacb-92b9-a6b7-e053-2a95a90aea02

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.