FDA.reportPublic FDA data

Private Label SPF 50 80 min Water Resistant

Product NDC
60232-0035
11-digit product format
602320035
Labeler code
60232
Product ID
60232-0035_6a3535ae-574f-48d8-bfc0-5b38f54c93ee
Type
HUMAN OTC DRUG
Nonproprietary name
homosalate, octisalate, zinc oxide sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
Swiss-American CDMO, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
Substance
HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
100; 50; 165 g/1000g; g/1000g; g/1000g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Private Label SPF 50 80 min Water Resistant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 g/1000g
OCTISALATE50 g/1000g
ZINC OXIDE165 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8849fa88-24c8-410d-b16e-60da38288f98Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-0035-1Private Label SPF 50 80 min Water Resistant1000 g in 1 TUBECREAM10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0035PRIVATE LABEL SPF 50 80 MIN WATER RESISTANT (HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN) CREAM [SWISS-AMERICAN CDMO, LLC]4Current NDC, 1 package rows20231115_8849fa88-24c8-410d-b16e-60da38288f98.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 94 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incf41e09bf-407d-65a4-e053-2a95a90a24362025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
application number: M020
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc25d9c520-431a-5546-e063-6394a90a4e0d2025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 30(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Inc1273012a-107c-1b19-e063-6394a90a53e42025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e5bf2c-88c2-d346-e063-6394a90abc782025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb728a-8c11-d041-e063-6294a90abb552025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incc0421c97-72bd-fcac-e053-2995a90aac282025-12-31WarningsExact identifier
application number: M020
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incb6492438-5dd2-030e-e053-2a95a90a2f9f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdort Incca8d2e20-c1f1-ecf2-e053-2a95a90a790f2025-12-31WarningsExact identifier
application number: M020
Eucerin Tinted Age Defense Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc125d053c-9418-5772-e063-6294a90a6d6d2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 15 SunscreenAVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc4812da-0686-7789-e053-2995a90a561f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb6861830-fdad-3829-e053-2a95a90a09712025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc0552256-d8cb-5473-e053-2995a90ad0d52025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60232-0035-1602320035011000 g in 1 TUBE (60232-0035-1) 1000 g2020-12-01NoNoCurrent