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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct66800-4094UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66800-409466800-4094-3UExcluded 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 Oil Free SPF 50 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE8 g/100g
AVOBENZONE3 g/100g
OCTISALATE4.5 g/100g
HOMOSALATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ded1f158-36d1-153f-e053-2995a90ace30Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-4094-3Coppertone Oil Free SPF 50 Sunscreen88 g in 1 TUBELOTION884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-4094COPPERTONE OIL FREE SPF 50 SUNSCREEN (AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%) LOTION [BEIERSDORF INC]3Current NDC, Legacy NDC, 1 package rows20250115_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 53 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
application number: M020
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
application number: M020
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 31ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d20a060-fedd-d2f2-e063-6294a90a5cc02026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 27ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d210edf-0966-87c8-e063-6394a90a30c72026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25 Blood OrangeAVOBENZONE, OCTINOXATEAnthony Skin LLC74853b40-a773-4488-98a9-c8029ad211342026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25AVOBENZONE, OCTINOXATEAnthony Skin LLC74d7bc30-db15-4cfc-8918-40897d54da702026-03-16WarningsExact identifier
application number: M020
CVS SPF 70 Sport Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26e66240-97ae-103d-e063-6394a90a9b5a2026-03-16WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beierdorf Incf2a06097-b066-8631-e053-2a95a90a9ffc2026-03-16WarningsExact identifier
application number: M020
Ultra Light Invisible SPF 40 sunscreenHOMOSALATE 8%, OCTISALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 4.0%RK Shea LLC02d59d96-0edb-472c-b730-148a2eb4fa4a2026-03-16WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SANDZINC OXIDECOSMAX USA4d31038e-a032-3ce9-e063-6394a90a889d2026-03-16WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce3d79b-fec5-8501-e063-6294a90a479d2026-03-15WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce59571-132a-c633-e063-6294a90a8d972026-03-15WarningsExact identifier
application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce63abb-e716-40de-e063-6394a90a6e762026-03-15WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.8d147089-709f-4468-a47d-9251e737c9a42026-03-15WarningsExact identifier
application number: M020
Cay Skin Isle Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECay Skin, Inc.d92a17c4-9827-5fb1-e053-2a95a90a9ca12026-03-13WarningsExact identifier
application number: M020
DAILY FACE SUNSCREEN Broad Spectrum SPF 30ZINC OXIDELilyana Naturals LLCe5f53e2f-6566-4eac-b9b5-7697abaf044b2026-03-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-4094-36680040940388 g in 1 TUBE (66800-4094-3) 88 g2022-04-010000-00-00NoNoCurrent