Home NDC 83286-014 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 Ingredient Strength ZINC OXIDE 12 g/100mL OCTINOXATE 7.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83286-014-01 Broad Spectrum SPF45 50 mL in 1 BOTTLE GEL 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-014 BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC] 1 Current NDC, 1 package rows 20250508_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 25 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE LG H&H Co., Ltd. 52ba9423-8b9b-38f7-e063-6394a90a95da 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Frosted Petal ZINC OXIDE Odacite 52ba9423-8b9d-38f7-e063-6394a90a95da 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn ZINC OXIDE Iris and Romeo 52bb700b-ff56-2286-e063-6394a90ac458 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Camellia ZINC OXIDE Iris and Romeo 52bb52ec-2cd7-f8cc-e063-6294a90aa61b 2026-05-26 Warnings Exact identifier application number: M020 Bubble Solar Mate Daily Mineral Sunscreen SPF 40 ZINC OXIDE Bubble Beauty, Inc. d2eca90f-9463-4d2f-975d-02f2802ded3e 2026-05-26 Warnings Exact identifier application number: M020 Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30 ZINC OXIDE Plexus Worldwide, LLC 55c391fa-37c6-47a2-befd-12888eb5fc18 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Suede ZINC OXIDE Iris and Romeo 52bb7505-a027-2533-e063-6294a90a2520 2026-05-26 Warnings Exact identifier application number: M020 Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc 9c909ae0-0117-4675-afc2-533d542f3659 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Carob ZINC OXIDE Iris and Romeo 52bbe9da-37f8-b3ba-e063-6394a90a139e 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Cameo ZINC OXIDE Iris and Romeo 52bc0174-872d-445b-e063-6294a90ab329 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Iconic ZINC OXIDE Iris and Romeo 52bbfdfe-dfc9-364f-e063-6294a90a646d 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulip Dew Bronze ZINC OXIDE Bloomeffects 52bc7f23-3594-3173-e063-6294a90a81ea 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulip Dew ZINC OXIDE Bloomeffects 0fcb1b45-c04d-310a-e063-6294a90ab56d 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Mauve Moment ZINC OXIDE Bloomeffects 52bd7522-81b5-6189-e063-6394a90a29b4 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Barely ZINC OXIDE Bloomeffects 52bd8a43-a8c2-897e-e063-6394a90a9f3d 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Fruit Punch ZINC OXIDE Bloomeffects 52bdc0ec-ac5e-4a57-e063-6294a90a0b3b 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy Pink ZINC OXIDE Bloomeffects 52bdc5cc-9742-4af6-e063-6294a90aba22 2026-05-26 Warnings Exact identifier application number: M020 Alleyoop Sun Serum Lip Oil - Daylight ZINC OXIDE NewAlley Innovations Inc 52be1071-67cb-f2c0-e063-6294a90a368c 2026-05-26 Warnings Exact identifier application number: M020 Alleyoop Sun Serum Lip Oil - Hazy ZINC OXIDE NewAlley Innovations Inc 52be3c9e-a791-5053-e063-6294a90a1b30 2026-05-26 Warnings Exact identifier application number: M020 Alleyoop Sun Serum Lip Oil - Whirlwind ZINC OXIDE NewAlley Innovations Inc 52be633a-fc64-7456-e063-6294a90a8fc0 2026-05-26 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83286-014-01 83286001401 50 mL in 1 BOTTLE (83286-014-01) 50 ml 2025-05-01 No No Current