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 251 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oars and Alps SPF 50 MineralZINC OXIDEOars and Alps LLCf395bc39-daa5-53b8-e053-2995a90a5f482024-12-20WarningsExact identifier
application number: M020
Babyganics Kids Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanics8a143645-3b52-4797-9b26-dc9dd63be38f2024-12-20WarningsExact identifier
application number: M020
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
application number: M020
Stokoderm Sunscreen PUREAVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATESC Johnson Professional USA, Inc.3ddf81e6-de78-4f2f-814b-c75eadcddb392024-12-20WarningsExact identifier
application number: M020
BabyGanics Sunscreen 30 SPFZINC OXIDE, OCTINOXATE, AND OCTISALATEKAS Direct LLC dba BabyGanics391a4ec3-b65b-4dbe-bc8f-cb67514c8ef12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAINOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ac9a5-f609-d804-e063-6394a90abd052024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ad424-16a8-66b1-e063-6394a90a07532024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afef9-758f-74e1-e063-6294a90a80722024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3276-7973-d33f-e063-6294a90a6ce12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TANOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afe24-d496-5745-e063-6394a90aa1b32024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b1f9a-34fd-cb50-e063-6394a90af9252024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SANDOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3236-3f3d-c9e8-e063-6394a90a74432024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b416d-ce02-3462-e063-6294a90a38f02024-12-19WarningsExact identifier
application number: M020
PuttisuTITANIUM DIOXIDE, ZINC OXIDEJellycup, Inc.a032331a-6724-d2cd-e053-2995a90ac15a2024-12-19WarningsExact identifier
application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCde493e30-d135-9def-e053-2995a90ae49a2024-12-19WarningsExact identifier
application number: M020
toty Ilumina CC Cream 1NTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe4efe14e-7d46-78c0-e053-2995a90a23642024-12-19WarningsExact identifier
application number: M020
Aruba Sun SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd8b28ce6-e938-c6e3-e053-2a95a90acc292024-12-19WarningsExact identifier
application number: M020
DCH Pain Relief Roll-OnLIDOCAINE HCL 4%Derma Care Research Labs, LLCfda35d37-f36e-efc8-e053-6294a90a2bb82024-12-19WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 KidsAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd53ff8f5-0b06-1e8b-e053-2a95a90ab9242024-12-19WarningsExact 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