Home NDC 53634-129 spf 30 Lip Balm
Product NDC 53634-129
11-digit product format 536340129
Labeler code 53634
Product ID 53634-129_5d348531-6f3f-22fc-e063-6294a90a0986
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form STICK
Route TOPICAL
Labeler Malin and Goetz Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-01
Substance TITANIUM DIOXIDE
Active strength 3.3 g/100mL
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 30 Lip Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 3.3 g/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53634-129-01 spf 30 Lip Balm 10 mL in 1 TUBE STICK 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53634-129 SPF 30 LIP BALM (TITANIUM DIOXIDE) STICK [MALIN AND GOETZ INC] 2 Current NDC, 1 package rows 20241004_fe1b3122-b6e2-46fa-e053-6394a90afd59.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 27 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC ZINC OXIDE Colorescience d46533c7-c92d-d161-e053-2995a90a8e4b 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Glow ZINC OXIDE Colorescience cdb5397a-c463-4b41-e053-2a95a90a9e03 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Matte ZINC OXIDE Colorescience cd879b3e-16a2-2cca-e053-2a95a90a14f8 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Body Shield ZINC OXIDE Colorescience cdb413bb-58ab-1e0f-e053-2995a90aab0f 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Flex ZINC OXIDE Colorescience cdb55347-aedd-4de6-e053-2a95a90afec7 2026-05-21 Warnings Exact identifier application number: M020 Odacite Flex Perfecting Mineral Drops Tinted Sunscreen ZINC OXIDE Odacite 52560b2d-ebb5-5d96-e063-6294a90a15ee 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Bronze ZINC OXIDE Colorescience cdb577e4-5c80-7eac-e053-2a95a90a105b 2026-05-21 Warnings Exact identifier application number: M020 Mineral SPF 30 Moisturizer MINERAL SPF 30 MOISTURIZER Dont Run Out Inc (DBA: Public Goods) 52462e7e-0c2c-6b64-e063-6394a90a4230 2026-05-21 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 52564e2f-983d-89ba-e063-6394a90ab424 2026-05-21 Warnings Exact identifier application number: M020 DRMTLGY Radiance Powder TITANIUM DIOXIDE, ZINC OXIDE DRMTLGY 15bda8d5-8c3c-6ba5-e063-6394a90a82d9 2026-05-21 Warnings Exact identifier application number: M020 Agent Natuer holi (sun) dewy tinted skin drops ZINC OXIDE Agent Natuer 043734b8-9aee-cdf1-e063-6294a90aec60 2026-05-21 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09bb5f97-f4db-a2d4-e063-6394a90a84fd 2026-05-21 Warnings Exact identifier application number: M020 Skin Metal Green Stealth ZINC OXIDE Skin Metal 47f562cc-48cc-97f9-e063-6294a90a7216 2026-05-21 Warnings Exact identifier application number: M020 Blume Sunburst Sunscreen ZINC OXIDE Blume 21ef2c6b-8ae7-8bcf-e063-6294a90ae9e1 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST13 KAMARI) ZINC OXIDE Ilia, Inc. b595ca2c-177e-b357-e053-2995a90a54f6 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST6 ORA) ZINC OXIDE Ilia, Inc. b59537d4-e1d8-53e4-e053-2995a90a2ce3 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST16 PAVONES) ZINC OXIDE Ilia, Inc. b595f1e9-36f7-615d-e053-2a95a90abb1c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO) ZINC OXIDE Ilia, Inc. b97dc2ac-dd6d-403d-e053-2995a90a0d9c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA) ZINC OXIDE Ilia, Inc. b595db16-7969-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST11 MATIRA) ZINC OXIDE Ilia, Inc. b595b5f0-dd3d-79ef-e053-2a95a90ad9fb 2026-05-21 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 53634-129-01 53634012901 10 mL in 1 TUBE (53634-129-01) 10 ml 2023-05-01 No No Current