FDA.reportPublic FDA data

Coppertone Oil Free Sunscreen SPF 30

Product NDC
66800-3900
11-digit product format
668003900
Labeler code
66800
Product ID
66800-3900_47461e1c-6213-2a9e-e063-6294a90a859a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 8%, Octisalate 4.5%, Octocrylene 6%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 8; 4.5; 6 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE3 g/100g
AVOBENZONE8 g/100g
HOMOSALATE4.5 g/100g
OCTISALATE6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5A68WGF6WM, G63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-3900-3Coppertone Oil Free Sunscreen SPF 3088 g in 1 TUBELOTION884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-3900COPPERTONE OIL FREE SUNSCREEN SPF 30 (AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%) LOTION [BEIERSDORF INC]3Current NDC, Legacy NDC, 1 package rows20250112_e451ecfb-cf17-c622-e053-2a95a90a4d4b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-3900-36680039000388 g in 1 TUBE (66800-3900-3) 88 g2022-02-010000-00-00NoNoCurrent