Home NDC 53329-092 Petroleum-Free Lip Balm
Product NDC 53329-092
11-digit product format 533290092
Labeler code 53329
Product ID 53329-092_40c101e4-f9c5-4766-e063-6294a90aaa46
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate and Oxybenzone
Dosage form LIPSTICK
Route TOPICAL
Labeler Medline Industries, LP
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-04-01
Substance OCTINOXATE; OXYBENZONE
Active strength 2; 4.5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 53329-092 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53329-092 53329-092-83 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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 Petroleum-Free Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 2 g/100g OXYBENZONE 4.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 95OOS7VE0Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-092-83 Petroleum-Free Lip Balm 4.2 g in 1 CONTAINER LIPSTICK 4.2 8 53329-092-83 Petroleum-Free Lip Balm 1 in 1 BOX LIPSTICK 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 CORN OIL INACTIVE INGREDIENT 8470G57WFM PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-092 PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, LP] 7 Current NDC, Legacy NDC, 2 package rows 20241204_6125d98a-6fc7-4f50-924e-3b1f7ee951f4.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 124 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Matte Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 3751544d-e093-3d19-e063-6394a90aefc3 2025-12-15 Exact identifier application number: M020 Lip Crack TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37edc05c-82c3-90fe-e063-6294a90aa601 2025-12-15 Exact identifier application number: M020 Restore And Replenish ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ed8525-6ae4-4e86-e063-6294a90afeb8 2025-12-15 Exact identifier application number: M020 Sunshade Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ee77dc-a96a-5efa-e063-6394a90affda 2025-12-15 Exact identifier application number: M020 Sunshade Mineral Sunscreen ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37df21f1-f36f-df43-e063-6294a90aea6f 2025-12-15 Exact identifier application number: M020 Tinted Moisturizing Mineral Sunscreen ZINC OXIDE EDIT EUROSPA, LLC 3751861d-3f3b-2ebd-e063-6294a90af898 2025-12-15 Exact identifier application number: M020 Non Tinted Moisturizing Mineral Sunscreen ZINC OXIDE EDIT EUROSPA, LLC 3751e278-b8b2-7bf4-e063-6394a90a4290 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 37521c60-2fee-861e-e063-6294a90ad69a 2025-12-15 Exact identifier application number: M020 MATTE Non Tinted Mineral Sunscreen ZINC OXIDE Allure Esthetics 3725d947-b1fa-3b50-e063-6394a90adf10 2025-12-15 Exact identifier application number: M020 GLOW Tinted Mineral Sunscreen ZINC OXIDE Allure Esthetics 37257bb2-d91d-6ff8-e063-6294a90a01b6 2025-12-15 Exact identifier application number: M020 Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35ce7133-badb-1bc4-e063-6294a90a7478 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bee5f9-68d6-6302-e063-6394a90ada88 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bfd54a-d7b7-f1a7-e063-6294a90a039b 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c03804-04e9-3d54-e063-6294a90a3407 2025-12-15 Exact identifier application number: M020 Deflectin Tinted Mineral Sunscreen ZINC OXIDE AEON AESTHETICS LLC 35d14660-8900-2cb0-e063-6394a90a317d 2025-12-15 Exact identifier application number: M020 Mineral Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf36c1-50c9-e848-e063-6294a90a6658 2025-12-15 Exact identifier application number: M020 Flash Invisible Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d2489e-4978-4fc3-e063-6294a90adfcc 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c010ad-e25d-f197-e063-6294a90a0efb 2025-12-15 Exact identifier application number: M020 Flash Tinted Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d28590-e746-7996-e063-6294a90ac7d8 2025-12-15 Exact identifier application number: M020 Mineral Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf03f4-200a-5643-e063-6394a90a9e02 2025-12-15 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 53329-092-83 53329009283 1 CONTAINER in 1 BOX (53329-092-83) / 4.2 g in 1 CONTAINER 1 container 2010-04-01 0000-00-00 No No Current