FDA.reportPublic FDA data

Coppertone Sport Sunscreen SPL 15

Product NDC
66800-3091
11-digit product format
668003091
Labeler code
66800
Product ID
66800-3091_47461823-09a6-1cd5-e063-6294a90a2fc5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-01
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
5; 3; 4.5; 2 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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct66800-3091UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66800-309166800-3091-7UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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 Sport Sunscreen SPL 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5 g/100g
OCTOCRYLENE3 g/100g
OCTISALATE4.5 g/100g
AVOBENZONE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
df4b522e-93d4-1284-e053-2a95a90a1cd9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-3091-7Coppertone Sport Sunscreen SPL 15207 g in 1 BOTTLE, PLASTICLOTION2075

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-3091COPPERTONE SPORT SUNSCREEN SPL 15 (AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%) LOTION [BEIERSDORF INC]4Current NDC, Legacy NDC, 1 package rows20250112_df4b522e-93d4-1284-e053-2a95a90a1cd9.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 60 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
application number: M020
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACKHOMOSALATE, OCTOCRYLENE, OCTISALATEPrinceville Productions, LLC, DBA Reunited Beauty4b961531-fbca-d1cf-e063-6294a90ab9a12026-02-24WarningsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.8f5e634c-765b-4ffe-bb12-753d64c90cf92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.e97bf30a-1465-4912-bd55-1e7dd993132b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.67efcd94-00af-477b-bd14-d1c7b95d305a2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen Mist SPF 100AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f642788c-3643-459a-b736-0c06d0cd32a92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.95ba2b33-f593-4e95-bd6e-5910d6aa51582026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3b85004a-8832-4eac-bd70-1e607ae7af4b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.7f0fc23b-2d70-4426-9d64-a6d2b643309f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.0ae9edd8-bf76-4bb2-ab78-c43c017ba4a52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f8960995-66b6-4197-8976-b318fe01488f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.c76f5639-bd0f-4987-8c70-224ee33bbbad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.8795b9a7-1938-4dd9-92ad-3c044feae1da2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f8bad95-8071-47b1-88a7-3a3f09f097b52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEBETTER INNOVATION LTD4b9a881a-835b-ef0c-e063-6394a90a94af2026-02-24WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE MOISTURIZER SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a9303-662f-9614-e063-6294a90a6b512026-02-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-3091-766800309107207 g in 1 BOTTLE, PLASTIC (66800-3091-7) 207 g2021-11-010000-00-00NoNoCurrent