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 63 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day MoistureHOMOSALATE, ZINC OXIDEWalmart Inc.b45d0ab6-b14d-4e3e-807a-886e6fffdded2026-02-11Warnings, Adverse reactionsExact identifier
application number: M020
Ganrek SUNSCREEN SPRAYER Broad Spectrum SPF 50SUNSCREEN SPF 50Guangzhou Meixi Biotechnology Co., Ltd.4a3adb04-5e3a-80bf-e063-6294a90a60472026-02-10WarningsExact identifier
application number: M020
Sugargirl Glow Up Body Illuminator Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC364d4d87-2d3e-4515-a3f2-1506d871699d2026-02-10WarningsExact identifier
application number: M020
Sugargirl Sunshine Body Illuminator Glowy Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea801e6c-44f9-4ec9-9022-5b637baf7d592026-02-10WarningsExact identifier
application number: M020
Poolside Golden Hour SPF 15 Sunscreen LipHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC7d0f8319-f0fa-4ea7-bb66-427c5a78145a2026-02-10WarningsExact identifier
application number: M020
Tanri Broad Spectrum SPF 30SUNSCREENI. Shay Cosmetics26d5b9d1-d669-3430-e063-6394a90ad7f22026-02-10WarningsExact identifier
application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDES+9d6ffe56-debc-4ad2-837b-fd7bb091a56f2026-02-09WarningsExact identifier
application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - FaceZINC OXIDESolavida, LLC4a694cdf-496b-3bc0-e063-6294a90af0d12026-02-09WarningsExact identifier
application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBENOW BEAUTY INC32bfb17c-5535-c016-e063-6394a90a18142026-02-09WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4a6b69ed-2739-d22a-e063-6294a90a1e522026-02-09WarningsExact identifier
application number: M020
SUNPLUS LIP LIFESUNSCREENI. Shay Cosmetics26d28286-e812-0fb3-e063-6394a90a338d2026-02-09WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbb86322d-ff30-4a54-97b5-1be2750671462026-02-06WarningsExact identifier
application number: M020
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Shiseido Americas Corporationf225a736-2ff7-4084-88a4-a8df5b043cce2026-02-06WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmerican Sales Company79dff6ec-d958-4bba-999b-da4aa67519f52026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneSUNSCREENRetail Business Services, LLC1dc325bb-d520-4897-b8f8-3f0ecba2274c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCd8a55217-ae50-4c7f-a440-f4de079d08ae2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 100AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCf2a4b432-118e-42a4-baeb-90614dccbd062026-02-06Warnings, Adverse reactionsExact 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