FDA.reportPublic FDA data

Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant

Product NDC
83005-0001
11-digit product format
830050001
Labeler code
83005
Product ID
83005-0001_1ba4b6fc-7878-d25e-e063-6394a90a8d60
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
SQWEEN LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
ZINC OXIDE
Active strength
150 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b5bf1c4c-7c48-423c-b4fc-52ae57f339fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83005-0001-1Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant60 mL in 1 TUBELOTION604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83005-0001SQWEEN 100% MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT (ZINC OXIDE) LOTION [SQWEEN LLC]4Current NDC, Legacy NDC, 1 package rows20240625_b5bf1c4c-7c48-423c-b4fc-52ae57f339fd.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 217 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32b5a19e-86d4-5ee1-e063-6394a90a12e22025-04-11WarningsExact identifier
application number: M020
LERINN ZINCPURE SUNMILK SPF 50ZINC OXIDESerrina Lin Skincare Inc32717b49-729c-a229-e063-6394a90a18fb2025-04-10WarningsExact identifier
application number: M020
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
application number: M020
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTOCRYLENE, ZINC OXIDE, OCTISALATESunstation USA LLC6007c125-f28a-45e5-b8f1-490ee04b78112025-04-09WarningsExact identifier
application number: M020
Pacifica Sun Dreams Illuminating SPF FoamHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPacifica Beauty, LLC2e0cb105-75c3-8032-e063-6394a90ab5022025-04-09WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANELG H&H CO., LTD.284cadf1-deb9-4f3d-e063-6394a90ab1222025-04-09WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDaa79b1a4-6b33-47c9-b55e-b813d9b222652025-04-09WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc OnlyZINC OXIDESPF Ventures, LLC3240cbe5-bfc8-17f7-e063-6394a90a1b982025-04-08WarningsExact identifier
application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral FaceZINC OXIDELG HOUSEHOLD & HEALTH CARE LTD.2eeac795-b74e-b3a3-e063-6294a90abf522025-04-08WarningsExact identifier
application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2ee9f271-b508-2304-e063-6294a90a37522025-04-08WarningsExact identifier
application number: M020
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarinsa43d0d4f-94de-4c4b-a17a-63a819d5d2932025-04-07WarningsExact identifier
application number: M020
Gangnam Glow Sunscreen 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30cc2e35-f752-8285-e063-6294a90afbf52025-04-07WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.26f8dc88-2096-4fa1-81ae-ea92fe1f353d2025-04-07WarningsExact identifier
application number: M020
Vacation Instant BrowningAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.13028f61-3f62-22cc-e063-6394a90a6bf12025-04-04WarningsExact identifier
application number: M020
LBri Pure n Natural SPF 30ZINC OXIDEL'BRI HEALTH & BEAUTY8350791d-5cf2-4358-9f85-9384d35be9f42025-04-03WarningsExact identifier
application number: M020
SHEER MINERAL SUNSCREENZINC OXIDEPlant Devas Inc. dba evanhealyf620ef44-f30c-4cc9-bc82-28dc4a47a8da2025-04-02WarningsExact identifier
application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD0116cffa-3415-746b-e063-6394a90ab3b32025-04-01WarningsExact identifier
application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD04293280-e74a-f293-e063-6394a90a06f62025-04-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83005-0001-18300500010160 mL in 1 TUBE (83005-0001-1) 60 ml2023-01-010000-00-00NoNoCurrent