Home NDC 66800-4094 Coppertone Oil Free SPF 50 Sunscreen
Product NDC 66800-4094
11-digit product format 668004094
Labeler code 66800
Product ID 66800-4094_47460679-8962-b4d5-e063-6394a90ab919
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%
Dosage form LOTION
Route TOPICAL
Labeler Beiersdorf Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-01
Substance OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength 8; 3; 4.5; 10 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 66800-4094 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66800-4094 66800-4094-3 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Coppertone Oil Free SPF 50 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 8 g/100g AVOBENZONE 3 g/100g OCTISALATE 4.5 g/100g HOMOSALATE 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66800-4094-3 Coppertone Oil Free SPF 50 Sunscreen 88 g in 1 TUBE LOTION 88 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66800-4094 COPPERTONE OIL FREE SPF 50 SUNSCREEN (AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%) LOTION [BEIERSDORF INC] 3 Current NDC, Legacy NDC, 1 package rows 20250115_ded1f158-36d1-153f-e053-2995a90ace30.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66800-4094-3 66800409403 88 g in 1 TUBE (66800-4094-3) 88 g 2022-04-01 0000-00-00 No No Current