FDA.reportPublic FDA data

Private Label SPF45 Water Resistant Paraben Free Sunscreen

Product NDC
60232-0006
11-digit product format
602320006
Labeler code
60232
Product ID
60232-0006_21e18883-f579-425a-a460-1e601e1b30be
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Zinc Oxide Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
Swiss-American CDMO, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-31
Substance
ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength
80; 75; 30 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 SPF45 Water Resistant Paraben Free Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE80 g/1000g
OCTINOXATE75 g/1000g
OCTISALATE30 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f997f4fc-7da5-433c-9a53-2030b489b4f6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-0006-1Private Label SPF45 Water Resistant Paraben Free Sunscreen50 g in 1 BOTTLELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0006PRIVATE LABEL SPF45 WATER RESISTANT PARABEN FREE SUNSCREEN (OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN) LOTION [SWISS-AMERICAN CDMO, LLC]3Current NDC, Legacy NDC, 1 package rows20231109_f997f4fc-7da5-433c-9a53-2030b489b4f6.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 66 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAMPTON SUN SPF50 SUNSHIELD BODY GLOWHOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%S&C Hampton Sun LLC26190992-9463-47ae-86a5-0dbc05be87732026-02-02WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENERite Aid Corporationfe9146ec-b85d-43da-a391-377960f2c7722026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
sheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation299a6690-9746-4410-a625-7636f0b4a7542026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENEFarmasi US LLC49dc6040-b400-7f5b-e063-6394a90ac7d72026-02-02WarningsExact identifier
application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50ZINC OXIDEe.l.f. Cosmetics, Inc535f798f-d21d-92b2-e063-6294a90a72c72026-02-02WarningsExact identifier
application number: M020
Sol de Janiero Rio Radiance SPF 50 BodyZINC OXIDECosmetic Solutions LLC2d54727d-5dcc-4792-85e8-1a2f21fe9e3d2026-02-02WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 50ZINC OXIDEDelta Ecommerce LLC47d9dc66-328f-4cab-e063-6394a90a279d2026-02-01WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f cosmetics,Inc.4b801bb3-8930-7e04-e063-6294a90adaa12026-02-01WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEARAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationcedd7a3e-3334-437f-a283-482bcd0064ee2026-01-30WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation372a8fba-b190-40fe-a1fc-fecf7f7afc352026-01-30Warnings, Adverse reactionsExact identifier
application number: M020
ALOE UP MEDICATED LIP BALM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLC859b6d3f-b1ca-4966-8f0c-f9afa0d5864c2026-01-30WarningsExact identifier
application number: M020
ALOE UP SPORT NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
application number: M020
Touch in SOL No Poreblem Airbrushed PrimerOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBONNE Co., Ltd4685ff24-0bb0-3502-e063-6394a90abfee2026-01-29WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Incc7650d20-7cb9-4861-8a30-cf4a9cd424e92026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Inc32c0613e-0f5a-47f5-b2f3-f32ae07cbc762026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Vacation Original Coconut SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.a9a0b558-b8e6-44ea-9b57-6938837a04fb2026-01-29WarningsExact identifier
application number: M020
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60232-0006-16023200060150 g in 1 BOTTLE (60232-0006-1) 50 g2011-08-310000-00-00NoNoCurrent