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 291 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Golden Glow Tanning Oil SPF-15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC748a9933-02a3-48c1-8636-8f0468f66a132024-07-17WarningsExact identifier
application number: M020
Tan De Soleil Orange Tanning Balm SPF 6HOMOSALATE, OCTISALATETANNING CLUB, LLC5343f359-6074-467c-99bb-f08a7ca2df412024-07-17WarningsExact identifier
application number: M020
Tanning Club Tanning SPF-8AVOBENZONE, OCTOCRYLENETANNING CLUB, LLCbbf9d61e-f2e6-4fde-baad-c412091c60b62024-07-17WarningsExact identifier
application number: M020
Mackenzies SPF 40 Ocean Safe SunscreenZINC OXIDENaturally Uncommon LLC1c314b70-45a7-1bd1-e063-6294a90a0d6b2024-07-17WarningsExact identifier
application number: M020
Bitchstix Eucalyptus Mint SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d764eb8-a0a7-d034-e063-6394a90aef242024-07-17WarningsExact identifier
application number: M020
Bitchstix Acai Berry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d765c28-f9da-15b6-e063-6394a90a057f2024-07-17WarningsExact identifier
application number: M020
Bitchstix Banana Kiwi SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e972-4fc1-9438-e063-6294a90a58452024-07-17WarningsExact identifier
application number: M020
Bitchstix Pineapple Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7699f4-3088-9436-e063-6294a90ab8522024-07-17WarningsExact identifier
application number: M020
Bitchstix Black Cherry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76824a-eac4-2d1f-e063-6294a90a8e662024-07-17WarningsExact identifier
application number: M020
Bitchstix Classic Coconut SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76aed7-308b-5cc5-e063-6394a90a45432024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Watermelon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e9b7-95af-6015-e063-6294a90a6f192024-07-17WarningsExact identifier
application number: M020
Bitchstix Vanilla Creme SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7713a9-de97-f0ff-e063-6294a90a80032024-07-17WarningsExact identifier
application number: M020
Bitchstix Grapefruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7723c7-984a-a789-e063-6394a90abdc42024-07-17WarningsExact identifier
application number: M020
Bitchstix Matcha and Aloe SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d771406-7c59-6052-e063-6394a90a01e62024-07-17WarningsExact identifier
application number: M020
Bitchstix Lemon Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d770a10-a9fa-94c4-e063-6294a90a137a2024-07-17WarningsExact identifier
application number: M020
Bitchstix Mango SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77866e-64f2-86d6-e063-6394a90a12922024-07-17WarningsExact identifier
application number: M020
Bitchstix Peachy Peach SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77c31e-c606-74b7-e063-6294a90a2cee2024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Lemon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77d785-56eb-e865-e063-6394a90acd012024-07-17WarningsExact identifier
application number: M020
Bitchstix Pomegranate SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffd-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix Strawberry Dragon Fruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77f460-e7be-30fe-e063-6394a90a8f1e2024-07-17WarningsExact 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