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 166 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join e.l.f Invisible Sunscreen SPF 35 AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE e.l.f. Cosmetics, Inc c2af5591-04df-4958-901e-dbe11698b844 2025-11-07 Warnings Exact identifier application number: M020 e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much ZINC OXIDE e.l.f. Cosmetics, Inc. 53d64042-f9ef-494d-a347-490c6a3c49b8 2025-11-07 Warnings Exact identifier application number: M020 e.l.f. Suntouchable Invisi SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f cosmetics,Inc. 547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d 2025-11-07 Warnings Exact identifier application number: M020 e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam ZINC OXIDE e.l.f. Cosmetics, Inc. b7d56015-4734-4ce4-b40d-64236df810e3 2025-11-07 Warnings Exact identifier application number: M020 elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween ZINC OXIDE e.l.f. Cosmetics, Inc. 4d9784b6-c54d-483d-a5ba-c557a05300ec 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOW ZINC OXIDE In The Pynk LLC 13badac4-e310-9589-e063-6394a90ab06b 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOUR ZINC OXIDE In The Pynk LLC 13bb8426-27cd-fbc9-e063-6294a90a8bf8 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOU ZINC OXIDE In The Pynk LLC 1365c6d8-64cb-3cb3-e063-6394a90a9d64 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 10w ZINC OXIDE e.l.f. Cosmetics, Inc c8a935e6-f7ac-4e3a-e053-2a95a90a877a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 11w ZINC OXIDE e.l.f. Cosmetics, Inc c8a94fb4-8752-587c-e053-2995a90a1e9a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 13w ZINC OXIDE e.l.f. Cosmetics, Inc c8a9bf6c-80cd-5884-e053-2a95a90a4a66 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 12w ZINC OXIDE e.l.f. Cosmetics, Inc c8a99278-21e0-c517-e053-2a95a90ade37 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 1C ZINC OXIDE e.l.f. Cosmetics, Inc c8a82c8b-e308-15e9-e053-2995a90afa2a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 14w ZINC OXIDE e.l.f. Cosmetics, Inc c8aa4629-1573-48a7-e053-2995a90aa86c 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 2w ZINC OXIDE e.l.f. Cosmetics, Inc. c8a82f54-839d-1de0-e053-2a95a90a2a97 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 4W ZINC OXIDE e.l.f. Cosmetics, Inc c8a83921-3181-396e-e053-2a95a90a02ee 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 3N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce3e-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 5N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce42-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 6w ZINC OXIDE e.l.f. Cosmetics, Inc c8a8ef6f-4426-a981-e053-2a95a90a9451 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen PEACH ZINC OXIDE e.l.f. Cosmetics, Inc c8aa931b-a3b4-6804-e053-2995a90a3eab 2025-11-07 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 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