FDA.reportPublic FDA data

Coppertone Oil Free and Shine Control Face Sunscreen SPF 45

Product NDC
66800-8164
11-digit product format
668008164
Labeler code
66800
Product ID
66800-8164_462bfa34-1c3f-098c-e063-6394a90adf12
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 10; 5; 10 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 and Shine Control Face Sunscreen SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE10 g/100g
OCTISALATE5 g/100g
OCTOCRYLENE10 g/100g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-8164-2Coppertone Oil Free and Shine Control Face Sunscreen SPF 4574 g in 1 TUBELOTION743

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-8164COPPERTONE OIL FREE AND SHINE CONTROL FACE SUNSCREEN SPF 45 (AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%) LOTION [BEIERSDORF INC]2Current NDC, 1 package rows20240630_f3d163b4-6774-4c2e-e053-2a95a90afd59.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66800-8164-26680081640274 g in 1 TUBE (66800-8164-2) 74 g2023-01-01NoNoHistorical