FDA.reportPublic FDA data

Broad Spectrum SPF45

Product NDC
83286-014
11-digit product format
832860014
Labeler code
83286
Product ID
83286-014_4f1a74ff-5ef6-4174-bb9b-b3ade1dc4f9c
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Octinoxate
Dosage form
GEL
Route
TOPICAL
Labeler
Drmtlgy, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
ZINC OXIDE; OCTINOXATE
Active strength
12; 7.5 g/100mL; g/100mL
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
Broad Spectrum SPF45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/100mL
OCTINOXATE7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-014-01Broad Spectrum SPF4550 mL in 1 BOTTLEGEL502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83286-014BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC]1Current NDC, 1 package rows20250508_0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8.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 29 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUMAVOBENZONE, HOMOSALATE, AND OCTISALATEInnisfree Corporation524264b8-d360-1d7b-e063-6394a90ab1152026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI)ZINC OXIDEIlia, Inc.b595bcc6-a1ab-25c9-e053-2995a90a87aa2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT)ZINC OXIDEIlia, Inc.b97f7fe9-c070-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE)ZINC OXIDEIlia, Inc.b959e3c3-ca92-ee41-e053-2a95a90a60642026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17 MIHO)ZINC OXIDEIlia, Inc.b595f875-b774-f847-e053-2995a90a28862026-05-21WarningsExact identifier
application number: M020
LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110COCTINOXATE, ZINC OXIDEBEL STAR S.A.526a8e50-b1de-47e5-e063-6394a90a3a292026-05-21WarningsExact identifier
application number: M020
Live Tinted Hueguard Skin TintZINC OXIDELive Tinted0ff39ab1-e8d3-cad9-e063-6394a90af0eb2026-05-21WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Quartz 001ZINC OXIDESunsolve MD Inc26a54f00-d84d-8fe3-e063-6394a90a03e82026-05-21WarningsExact identifier
application number: M020
Inde WildZINC OXIDEInde Wild01529c59-8806-6423-e063-6294a90a49e32026-05-21WarningsExact identifier
application number: M020
CARDON SPF and MOISTURIZERAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc52122434-6e6f-39fc-e063-6394a90a1fd02026-05-21WarningsExact identifier
application number: M020
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45OCTINOXATE AND ZINC OXIDEMerz North America, Inc62c822d9-c8ed-4b95-8d88-806295f5a9362026-05-20WarningsExact identifier
application number: M020
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
application number: M020
Stream2Sea SPF 50ZINC OXIDEStream2Sea5243f110-fe5b-946a-e063-6394a90add7e2026-05-20WarningsExact identifier
application number: M020
SP-FB0D-L0TNBarrierProtectionMineralSunscreenBARRIER PROTECTION MINERAL SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)50786950-1c31-e467-e063-6394a90a6fc82026-05-20WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
application number: M020
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30OCTINOXATE AND ZINC OXIDEMerz North America, Inc.e120a659-0dfc-42ca-8158-58e8a0b457e52026-05-20WarningsExact identifier
application number: M020
Evereden Cooling Mineral Sunstick SPF 30ZINC OXIDEEden Brands Inc.4af9e668-0d88-74ad-e063-6394a90a52432026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522addd5-9701-3234-e063-6294a90aaa9d2026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522b4aca-fe5b-dfe2-e063-6394a90ae5782026-05-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-014-018328600140150 mL in 1 BOTTLE (83286-014-01) 50 ml2025-05-01NoNoCurrent