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 118 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39959db9-5ee1-a27c-e063-6394a90a1e10 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995f556-20fe-3e64-e063-6294a90a5efe 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995385b-b10b-ca5c-e063-6294a90af43f 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3994aa84-30b4-3dc4-e063-6394a90a23e7 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39947913-f1cc-25d2-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35425e24-3e2c-51db-e063-6394a90a5580 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396fe2ca-eb29-5952-e063-6294a90ab279 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f91b3-3326-3239-e063-6294a90a5df9 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35422370-eb55-049c-e063-6294a90ad0a4 2025-12-15 Exact identifier application number: M020 Eclipse Face Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f0151-2d0d-f4da-e063-6394a90a5f7f 2025-12-15 Exact identifier application number: M020 Eclipse Body Non Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f56df-d0de-1344-e063-6294a90a46ea 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted TITANIUM DIOXIDE, ZINC OXIDE DENISE BELL SKIN CARE 396eb781-5947-3665-e063-6294a90a38dd 2025-12-15 Exact identifier application number: M020 Sun Veil Illuminating Sunscreen SPF30 ZINC OXIDE Koco Life LLC 46001097-540e-65da-e063-6294a90af299 2025-12-15 Warnings Exact identifier application number: M020 Mineral Primer tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 3542d8d3-35a3-7d63-e063-6394a90a6fd1 2025-12-15 Exact identifier application number: M020 Mineral Primer non-tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 354357de-1a85-3bdb-e063-6294a90aa9a2 2025-12-15 Exact identifier application number: M020 Mineral Primer tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 35433254-1dc8-a8f3-e063-6394a90a29f0 2025-12-15 Exact identifier application number: M020 Sun Therapy Sunscreen ZINC OXIDE Skin Therapy Studio LLC 3544916b-3f63-3a7a-e063-6394a90ae507 2025-12-15 Exact identifier application number: M020 Ultra Zinc Mineral Non Tinted ZINC OXIDE Skin Therapy Studio LLC 3545d603-3d01-c51d-e063-6394a90a1599 2025-12-15 Exact identifier application number: M020 Sun Therapy Sunscreen ZINC OXIDE Skin Therapy Studio LLC 357efafb-aa1c-0d69-e063-6394a90a5135 2025-12-15 Exact identifier application number: M020 Ultra Zinc Mineral Non Tinted ZINC OXIDE Skin Therapy Studio LLC 35806102-6919-116f-e063-6294a90ad922 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