Home NDC 83286-008 Broad Spectrum SPF45
Product NDC 83286-008
11-digit product format 832860008
Labeler code 83286
Product ID 83286-008_f6752fc2-97f8-4812-bd32-c91fb9b703be
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 2025-04-08
Marketing end 2027-04-30
Substance ZINC OXIDE; OCTINOXATE
Active strength 12; 7.5 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
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 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 g/100g OCTINOXATE 7.5 g/100g
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 83286-008-01 Broad Spectrum SPF45 57 g in 1 BOTTLE GEL 57 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-008 BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC] 2 Current NDC, 1 package rows 20250508_ce93b371-26ab-4493-98e0-98234c3a9ba6.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 183 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE Toshiki Pigment Co., Ltd. b9eba15f-493a-43c9-e053-2995a90a0451 2025-10-06 Warnings Exact identifier application number: M020 Apple Lip Balm with Aloe Vera BROAD SPECTRUM SPF 15 SUNSCREEN LIP BALM Durvet, Inc. 6dcbb2cd-e690-4970-8cf1-08ca539d3602 2025-10-06 Warnings Exact identifier application number: M020 PURE SOL SPF 50 Daily Moisturizer ZINC OXIDE Brand 2022b LLC 4051506c-fc13-cd22-e063-6394a90a977e 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer) ZINC OXIDE Brand 2022b LLC 4051ced5-85cf-6211-e063-6394a90a09fc 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen ZINC OXIDE Brand 2022b LLC 4051d241-6890-2b06-e063-6294a90aa09d 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 37 Tinted Moisturizer ZINC OXIDE TITANIUM DIOXIDE Brand 2022b LLC 4052c4e4-2105-80c0-e063-6294a90af41d 2025-10-04 Warnings Exact identifier application number: M020 PLAY Antioxidant Body Mist SPF 50 - Vanilla Orchid AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7a9722-d211-e861-e063-6294a90a6cdc 2025-10-02 Warnings Exact identifier application number: M020 Kids Mineral Sunscreen SPF50 SUNSCREEN Hello Bello 01cc554b-9241-d891-e063-6394a90a8450 2025-10-02 Warnings Exact identifier application number: M020 HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB SUNSCREEN SPF 50 IHerb, LLC 3cab1598-5ef3-df73-e063-6394a90ab1e2 2025-10-01 Warnings Exact identifier application number: M020 Moisturizing Rich Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC 36c3ba26-ca25-7498-e063-6294a90a47fc 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 Shade 1 ZINC OXIDE Dime Beauty Co, LLC 07104cbf-0446-a053-e063-6394a90ab41f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 ZINC OXIDE Dime Beauty Co, LLC 07503a1f-d530-e3bb-e063-6294a90a8ae3 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC e38deed3-e1e2-0b1d-e053-2a95a90a547f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC f2a59fa4-f19c-a15f-e053-2a95a90a6ace 2025-10-01 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414b88ca-a3df-5e42-e063-6294a90a69ba 2025-10-01 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREE ZINC OXIDE KENDO HOLDINGS INC 19120c3f-8fc0-62c3-e063-6394a90a30f3 2025-09-30 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE KENDO HOLDINGS INC 1d26bfb0-3c05-4a0c-9d4b-810359222730 2025-09-30 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER ZINC OXIDE KENDO HOLDINGS INC fd16def1-4c88-3ad0-e053-6294a90ab088 2025-09-30 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND ZINC OXIDE KENDO HOLDINGS INC f92b75bd-c5b7-0320-e053-6394a90ab4c3 2025-09-30 Warnings Exact identifier application number: M020 OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30 ZINC OXIDE KENDO HOLDINGS INC f92ae08e-0bca-4775-e053-6394a90ab3d6 2025-09-30 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83286-008-01 83286000801 57 g in 1 BOTTLE (83286-008-01) 57 g 2025-04-08 2027-04-30 No No Historical