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 206 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orchidee Double Defense Skin ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.74b3c33f-5db5-460d-97be-fa495b6252492025-06-27WarningsExact identifier
application number: M020
GHOSTEDZINC OXIDESpoogea5b611c3-d4d3-461e-84d8-d04a29c749022025-06-26WarningsExact identifier
application number: M020
Dew MeZINC OXIDESpooge0c4b429b-7dd5-4929-95af-d02b6770f1212025-06-26WarningsExact identifier
application number: M020
Zinc FIVE-0 baby and kids mineral sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38744f77-4845-eac4-e063-6294a90af6482025-06-26WarningsExact identifier
application number: M020
NYU Langone Health Lip BalmZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd38745b55-8da5-4627-e063-6394a90a24ca2025-06-26WarningsExact identifier
application number: M020
Active Skin Repair hydrating daily sunscreenZINC OXIDEInnovacyn, Inc.1eacdde1-f990-4962-92f1-3f41a8a3b1932025-06-26WarningsExact identifier
application number: M020
CheekyZINC OXIDESpooged377379a-a1be-4acf-9df5-2ff73fb5c83d2025-06-26WarningsExact identifier
application number: M020
TheOGZINC OXIDESpoogea2f781a8-eba8-48f5-8680-9235aae8a4ff2025-06-26WarningsExact identifier
application number: M020
Reef safe - Vitamin C sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0763-74e9-3a71-e063-6394a90a46fb2025-06-25WarningsExact identifier
application number: M020
Reef safe - acne-prone sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f079c-5730-5111-e063-6394a90af2d82025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Face sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0f79-016f-71a7-e063-6394a90a92862025-06-25WarningsExact identifier
application number: M020
Reef safe - Baby zinc sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f320c-9144-78b8-e063-6394a90a2e9d2025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Sport sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385ff227-1656-960a-e063-6294a90a913c2025-06-25WarningsExact identifier
application number: M020
Thermasun SPF50 Mineral Zinc facial sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ecba0-2f7f-9178-e063-6394a90a44c42025-06-25WarningsExact identifier
application number: M020
Reefsun sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ec055-4ae7-9d2d-e063-6394a90a83c02025-06-25WarningsExact identifier
application number: M020
SR Active Sheer Zinc Face Stick SPF 5020.6% ZINC OXIDESkinresource.md, L.L.C.29928ab0-4467-57cb-e063-6394a90ac4d32025-06-25WarningsExact identifier
application number: M020
Sun Protection SPF 50AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5%Skinresource.md, L.L.C.2a0c3dd1-4bc0-6664-e063-6294a90af4b32025-06-25WarningsExact identifier
application number: M020
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
application number: M020
Blooskim BEEF TALLOW SUNSCREENNON-NANO ZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.384903fa-e739-08b8-e063-6394a90a76532025-06-24WarningsExact identifier
application number: M020
Walgreens SPF 55 Sheer Face Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf05b45e2-2fcd-631e-e053-2995a90ad3342025-06-24WarningsExact 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