FDA.reportPublic FDA data

Coppertone Protect and Tan SPF 30

Product NDC
66800-0082
11-digit product format
668000082
Labeler code
66800
Product ID
66800-0082_4746d39e-9b6b-38bb-e063-6294a90ad596
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 14%, Octisalate 4.5%, Octocrylene 9%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-02
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 14; 4.5; 9 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 Protect and Tan SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE14 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE9 g/100g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-0082-1Coppertone Protect and Tan SPF 30148 g in 1 BOTTLE, PLASTICLOTION1485

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-0082COPPERTONE PROTECT AND TAN SPF 30 (AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%) LOTION [BEIERSDORF INC]4Current NDC, Legacy NDC, 1 package rows20241204_d3994886-2ebe-a9d2-e053-2995a90aaf9a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-0082-166800008201148 g in 1 BOTTLE, PLASTIC (66800-0082-1) 148 g2021-11-020000-00-00NoNoCurrent