Home NDC 85339-203 SPF 40 Broad Spectrum
Product NDC 85339-203
11-digit product format 853390203
Labeler code 85339
Product ID 85339-203_45b3a342-878a-6db5-e063-6294a90aa648
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Teton Dermatology Holdings, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-27
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 38; 80 mg/g; mg/g
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 SPF 40 Broad Spectrum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 38 mg/g TITANIUM DIOXIDE 80 mg/g
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 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85339-203-50 SPF 40 Broad Spectrum 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85339-203 SPF 40 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TETON DERMATOLOGY HOLDINGS, INC.] 1 Current NDC, 1 package rows 20250515_35081ce0-2203-ab86-e063-6294a90aefd5.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 241 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Future Youth Daily Turnaround Hydrating Moisturizer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Pacifica Beauty, LLC 0324275f-13bc-e7b8-e063-6294a90a6902 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Super Lit SPF 30 ZINC OXIDE Pacifica Beauty, LLC f3d3eee2-a5d9-113b-e053-2995a90a7057 2025-01-03 Warnings Exact identifier application number: M020 Kind Tint SPF 30 ZINC OXIDE Pacifica Beauty, LLC f421cbf7-cfae-5eae-e053-2995a90ab35c 2025-01-03 Warnings Exact identifier application number: M020 Vegan Collagen Every Day SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE Pacifica Beauty, LLC f449da32-5ade-2c78-e053-2a95a90a27a1 2025-01-03 Warnings Exact identifier application number: M020 Members Mark SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sam's West Inc 2b354ab6-f241-676f-e063-6394a90a5893 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Mint Lip Balm LIP BALM Casad Company Inc. 3214bff3-e133-43ca-946d-f4c5dd074760 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Lip Balm LIP BALM Casad Company Inc. d27398d3-98b0-4f70-997e-6ed02559594f 2025-01-03 Warnings Exact identifier application number: M020 Cherry Lip Balm LIP BALM Casad Company Inc. b262645e-f069-420d-90ac-9eb4b82236d8 2025-01-03 Warnings Exact identifier application number: M020 Peppermint Lip Balm LIP BALM Casad Company Inc. 46a4b6d1-37e4-471d-a41b-57afe8bd9f2f 2025-01-03 Warnings Exact identifier application number: M020 Beeswax Lip Balm LIP BALM Casad Company Inc. 5301398d-82f8-495e-b3ec-0938eca16369 2025-01-03 Warnings Exact identifier application number: M020 Spearmint Lip Balm LIP BALM Casad Company Inc. ba9b5420-60b0-4528-9898-a0a5287a2aee 2025-01-03 Warnings Exact identifier application number: M020 Pomegranate Lip Balm LIP BALM Casad Company Inc. 4e943a8a-f627-4e28-bdd7-c2b63be5dca3 2025-01-03 Warnings Exact identifier application number: M020 Tropical Lip Balm LIP BALM Casad Company Inc. 5e730d21-b810-4b84-9c85-0343ab0c8d5a 2025-01-03 Warnings Exact identifier application number: M020 Green Defense Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Farmacy Beauty LLC adf0f50f-6357-bc1f-e053-2a95a90ad997 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Bamboo ZINC OXIDE EVER FAME PTE. LTD. 2abbc7fb-ea5d-9c68-e063-6394a90a88d2 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Almond ZINC OXIDE EVER FAME PTE. LTD. 2abbd076-825d-df76-e063-6294a90a22fc 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Butter ZINC OXIDE EVER FAME PTE. LTD. 2abbf4a1-a404-b36c-e063-6394a90a41a8 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Butterscotch ZINC OXIDE EVER FAME PTE. LTD. 2abc0d57-cf8b-2508-e063-6294a90a8ee0 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Cappuchino ZINC OXIDE EVER FAME PTE. LTD. 2abc72f5-d1fd-c4f4-e063-6394a90aab9a 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Camel ZINC OXIDE EVER FAME PTE. LTD. 2abc3ffb-ce18-6a64-e063-6294a90a8ab1 2025-01-02 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 85339-203-50 85339020350 53 g in 1 BOTTLE, PUMP (85339-203-50) 53 g 2023-10-27 No No Current