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 307 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EA EIGHT HR LIP SHEER TINTSOXYBENZONE, PADIMATE O, PETROLATUMREVLONb671d630-2b71-66d2-e053-2a95a90a84612024-01-12WarningsExact identifier
application number: M020
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
application number: M020
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
application number: M020
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
application number: M020
Aruba Aloe broad spectrum SPF 15 Lip sunscreen and MoisturizerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce2024-01-11WarningsExact identifier
application number: M020
Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15OCTINOXATE, OCTISALATE, AND ZINC OXIDEGuthy-Renker LLC6437fbf6-c84b-497e-bf69-b20153d4c7062024-01-11WarningsExact identifier
application number: M020
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
application number: M020
Principal Secret Reclaim Sunscreen For Face and Body SPF 30MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDEGuthy-Renker LLC4a183aa2-deda-4b26-a126-6f98cfbdb0f32024-01-10WarningsExact identifier
application number: M020
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
application number: M020
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
application number: M020
Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8OCTINOXATE AND OCTISALATEGuthy-Renker LLCf4310455-8b3f-40a9-8674-fe7fc3abaced2024-01-08WarningsExact identifier
application number: M020
Aruba Sun SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Derma Care Research Labs,LLCd8b4f8c4-811b-4139-e053-2995a90a04c22024-01-05WarningsExact identifier
application number: M020
MIAMI BEACH BUM Save Face Sheer Mineral Sunscreen SPF 50ZINC OXIDEMIAMI BEACH BUM95675bd2-a0ae-44db-a75a-5c432e9614952024-01-04WarningsExact identifier
application number: M020
GINZING SPF 30 DAILY MOISTURIZERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0e106c03-4c25-5bfb-e063-6294a90ab3e12024-01-03WarningsExact identifier
application number: M020
Avon Anew Platinum Day-Cream SPF 25 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Avon Company148203ef-7d73-369c-e063-6394a90a0e582024-01-03WarningsExact identifier
application number: M020
Avon Anew Ultimate Day Multi-Performance-Cream SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company14833e71-704d-9a88-e063-6394a90a31b22024-01-03WarningsExact identifier
application number: M020
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
application number: M020
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
application number: M020
Garnier green labs Replumping HyaluMelon Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc5bece3c9-c310-4fb2-b644-507407fcfb082024-01-02WarningsExact identifier
application number: M020
Josie Maran Argan Daily Moisturizer SPF47 Protect and PerfectZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.cb91c130-45d4-46a0-9628-50e701a6960c2024-01-02Boxed warning, WarningsExact 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