FDA.reportPublic FDA data

Coppertone Glow Sunscreen SPF 50

Product NDC
66800-0004
11-digit product format
668000004
Labeler code
66800
Product ID
66800-0004_4746dd70-39eb-ca5d-e063-6394a90a5202
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%
Dosage form
AEROSOL, SPRAY
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; 90; 45; 90 mg/g; mg/g; mg/g; mg/g
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 Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE90 mg/g
OCTISALATE45 mg/g
OCTOCRYLENE90 mg/g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-0004-5Coppertone Glow Sunscreen SPF 50142 g in 1 CANAEROSOL, SPRAY1425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-0004COPPERTONE GLOW SUNSCREEN SPF 50 (AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%) AEROSOL, SPRAY [BEIERSDORF INC]4Current NDC, Legacy NDC, 1 package rows20241207_b60dcbd1-42d0-646f-e053-2a95a90a497d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-0004-566800000405142 g in 1 CAN (66800-0004-5) 142 g2020-11-020000-00-00NoNoCurrent