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 249 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RV Illuminance Serum Tint Broad Spectrum 15 Rich SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6ba3-b5da-f2f7-e063-6394a90a86ae2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Soft NutmegFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b856a-d714-892c-e063-6294a90a4ae92024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 SandalwoodFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b856a-d712-892c-e063-6294a90a4ae92024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Tan SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b5cca-4e4f-efb6-e063-6294a90a62062024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Warm CaramelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b9147-3c7a-d549-e063-6394a90a68692024-12-24WarningsExact identifier
application number: M020
Nu Skin 180 Degree UV Defense Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc91a22a5a-87fd-4db0-9183-caebee4013042024-12-24WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incaefd7884-6bc3-4b0b-ba36-1f3e8fe49f932024-12-23WarningsExact identifier
application number: M020
Attitude mineral sunscreen tropical SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude56e57ca0-d163-4580-9bca-747acce4d69f2024-12-23WarningsExact identifier
application number: M020
(S)UNDERCOVER SPF 50ZINC OXIDETUBBY TODDdca478a0-c319-68d8-e053-2a95a90a10fc2024-12-23WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Ince7bef1da-ea35-4306-b043-73d566a7e6bb2024-12-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc46aa9917-52ac-4c57-afde-366d2d3ca2002024-12-23WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1d115945-fa1b-485b-bf53-44308fd1a6302024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATEL'Oreal USA Products Inc7cc920de-c91f-4040-a0b9-ea216d6f9bd72024-12-23WarningsExact identifier
application number: M020
Kids SPF50Plus Mineral Sunscreen Rollerball Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd3bdda65-bcb4-42d9-84af-d14c7f4421bd2024-12-23WarningsExact identifier
application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin ProtectantDIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Ince8539a43-db85-451c-bce8-2c488f3dc40d2024-12-23WarningsExact identifier
application number: M020
NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE,OCTISALATE AND OCTOCRYLENELOreal USA Products Inc81093d80-dcaf-4555-98b2-48ce7eb84d0c2024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATESICOS ET CIEc634eaab-f014-4155-a40b-9030e358ec122024-12-23WarningsExact identifier
application number: M020
Kids SPF50 Plus Mineral Sunscreen Continuous Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd5ffe993-de8f-4623-a010-9cb8dd70de072024-12-23WarningsExact identifier
application number: M020
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc8b298516-70df-47ab-834f-51dcde28a43a2024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE6a14ee23-28c9-4704-8af9-d1c4db0d92562024-12-23WarningsExact 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