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 174 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KidsBliss Baby and Kids Mineral Sunscreen SPF50 ZINC OXIDE VeganicSKN 2dfa236f-128b-17bb-e063-6294a90aa29c 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd7477-445f-d1d5-e063-6394a90a4607 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun reef safe Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd936b-0ea6-03a2-e063-6394a90a4fba 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 years ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de1cd7-fdfd-7f7a-e063-6394a90a9b5c 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 7 years to adult ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de09dc-544f-9780-e063-6394a90acd27 2025-10-24 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Sunscreen SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 23670a30-6619-0651-e063-6394a90af978 2025-10-24 Warnings Exact identifier application number: M020 PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 397b4338-fec8-5228-e063-6394a90ad97d 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 38c80373-1d5a-c7f4-e063-6294a90aa9c2 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35 ZINC OXIDE, TITANIUM DIOXIDE THG Beauty USA LLC 254b4692-a459-6119-e063-6394a90a0a60 2025-10-23 Warnings Exact identifier application number: M020 AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENE CHOP SAVER FRESH CITRUS SPF 15 LIP BALM Good for the Goose Products, LLC 2786cec8-0b8e-9c83-e063-6394a90ab338 2025-10-23 Warnings Exact identifier application number: M020 Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Naturopathica Holistic Health 41d75815-e281-bf88-e063-6294a90afeff 2025-10-23 Warnings Exact identifier application number: M020 Thrive Daily Sunscreen For Sensitive Skin SPF 30 ZINC OXIDE Thrive Natural Care, Inc 128e1a3a-df40-f51c-e063-6394a90a1902 2025-10-23 Warnings Exact identifier application number: M020 Thrive Bodyshield 50 SPF 50 ZINC OXIDE Thrive Natural Care, Inc 12d9e1d0-c59c-f770-e063-6294a90a8191 2025-10-23 Warnings Exact identifier application number: M020 Bondi Sands Broad Spectrum SPF 60 Sunny Cream Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Baxter Laboratories Pty. Ltd. 2861453a-12e9-faeb-e063-6394a90a527c 2025-10-23 Warnings Exact identifier application number: M020 Good Defense Daily Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE Offspring Beauty Co. 2a462e60-6353-f791-e063-6294a90a62e3 2025-10-23 Warnings Exact identifier application number: M020 Skin Solution Multi-Serum Skin Tint SPF 40 ZINC OXIDE Offspring Beauty Co. 2d598f5d-d23f-6d54-e063-6294a90a778d 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Kids ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c7a1be-87e5-1f87-e063-6394a90ad876 2025-10-23 Warnings Exact identifier application number: M020 Aussiezinc Mineral Sunscreen SPF50 Baby ZINC OXIDE Veganic SKN Limited 16cc5178-e4c7-38eb-e063-6294a90a66de 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Everyday ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c9e96f-0299-095b-e063-6394a90a411d 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light Tint ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c9f293-58c8-1a6f-e063-6394a90adc1f 2025-10-23 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