FDA.reportPublic FDA data

Coppertone Protect and Tan Sunscreen SPF 45

Product NDC
66800-0079
11-digit product format
668000079
Labeler code
66800
Product ID
66800-0079_4746d499-7b48-5a63-e063-6294a90a5128
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdort Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-03
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 15; 5; 100 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 Sunscreen SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE15 g/100g
OCTISALATE5 g/100g
OCTOCRYLENE100 g/100g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-0079-1Coppertone Protect and Tan Sunscreen SPF 45148 g in 1 TUBELOTION1485

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-0079COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45 (AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%) LOTION [BEIERSDORT INC]4Current NDC, Legacy NDC, 1 package rows20241204_d39a009d-1f33-88bb-e053-2a95a90a03a0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-0079-166800007901148 g in 1 TUBE (66800-0079-1) 148 g2021-11-030000-00-00NoNoCurrent