FDA.reportPublic FDA data

Coppertone Glow Hydragel Sunscreen SPF 30

Product NDC
66800-4480
11-digit product format
668004480
Labeler code
66800
Product ID
66800-4480_4746f008-cafb-e19b-e063-6394a90aadee
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 9%
Dosage form
GEL
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-02
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 45; 90 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Coppertone Glow Hydragel Sunscreen SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE45 mg/mL
OCTOCRYLENE90 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-4480-4Coppertone Glow Hydragel Sunscreen SPF 30133 mL in 1 TUBEGEL1338

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-4480COPPERTONE GLOW HYDRAGEL SUNSCREEN SPF 30 (AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%) GEL [BEIERSDORF INC]7Current NDC, Legacy NDC, 1 package rows20241207_b60c2a38-ef92-0dff-e053-2995a90a47c4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-4480-466800448004133 mL in 1 TUBE (66800-4480-4) 133 ml2020-11-020000-00-00NoNoCurrent