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 207 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b2b1ed5-8e53-00f3-e063-6394a90a14f82025-06-24WarningsExact identifier
application number: M020
Walgreens Double Restorative Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY38569431-56b6-5f56-e063-6394a90ad24f2025-06-24WarningsExact identifier
application number: M020
Shade SPF30 Climate ControlOCTISALATE, OCTOCRYLENE, ZINC OXIDEMicro Current Technology, Inc.34080e9c-1637-cf25-e063-6394a90ace762025-06-24WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVcca65f6a-935f-48d4-a07d-831ab6027db02025-06-24WarningsExact identifier
application number: M020
Reef safe - Hydrating sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385e8966-963d-0814-e063-6394a90a06e32025-06-24WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTDf76a4f0d-e3a6-4bd4-b1ab-09d690976d962025-06-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf459c27e-e607-47ba-e053-2a95a90a901f2025-06-22WarningsExact identifier
application number: M020
BISUTANG SunscreenBISUTANG SUNSCREENGuangdong Bisutang Biotechnology Co Ltd37fdb01b-929e-6a60-e063-6394a90a94e02025-06-20Exact identifier
application number: M020
AVON BEYOND GLOW SUN MILKAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.38045f75-42c0-7abb-e063-6294a90a8db62025-06-20WarningsExact identifier
application number: M020
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
application number: M020
LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATEBel Star S.A. (Colombia)b5e47c63-7e82-34fc-e053-2a95a90a767c2025-06-20WarningsExact identifier
application number: M020
Proven Personalized Day Moisturizer Sunscreen SPF 30ZINC OXIDEProven Skincare5275d2c5-96e8-424d-a3c8-feea778191e42025-06-20WarningsExact identifier
application number: M020
LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf9266687-73d2-dac9-e053-6394a90ac2a12025-06-20WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEBEL STAR SAfd0465aa-df1e-ce1c-e053-6294a90a23022025-06-20WarningsExact identifier
application number: M020
FEIBTH TALLOW SUNSCREENTALLOW SUNSCREENGuangzhou Qiexiran Cosmetics Co., Ltd.37ead2b1-12d4-af92-e063-6394a90af0d62025-06-19WarningsExact identifier
application number: M020
LipBOMBTITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ef4c1e-2183-a277-e063-6394a90ae2df2025-06-19Exact identifier
application number: M020
Bioresist reinforcing effect face moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S A99d7525d-b636-7f8e-e053-2a95a90a20802025-06-19WarningsExact identifier
application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude TranslucideOCTINOXATE, ZINC OXIDEBEL STAR S Ac4d56723-3953-fb8e-e053-2a95a90a69d32025-06-19WarningsExact identifier
application number: M020
SPF 50 Daily UV Defense Broad Spectrum SunscreenOCTINOXATE, ZINC OXIDEVi Medical Products, INC2d814f8a-23b5-209f-e063-6394a90a50912025-06-19WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact 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