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 46 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arizona Sun Kids Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10f60367-6681-a589-e063-6394a90a6bb8 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen Water Resistant SPF 30 SUNSCREEN Arizona Sun Products 115b4d4c-51f1-ad62-e063-6294a90a3e53 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10e48195-7bae-2422-e063-6394a90a261c 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10e276e4-81f1-9429-e063-6394a90a800d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 106a9608-f7a4-0f8c-e063-6394a90a26ab 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fced72-39f9-f3a3-e063-6294a90a8b73 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc2a82-260c-7cd3-e063-6394a90af2c1 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd9aa5-dbd6-e5a7-e063-6394a90a3eac 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc93a7-f5be-965d-e063-6394a90ab335 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd1661-1b91-b65b-e063-6394a90af89b 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Lipkist Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fbcb81-2735-53c8-e063-6394a90ab0fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd8776-99f8-e5a4-e063-6394a90a2033 2026-04-09 Warnings Exact identifier application number: M020 uLOOK Sunscreen SPF 50 SUNSCREEN HAMEX GLOBAL COSMETICS LLC 4e05588c-486b-60e0-e063-6294a90af457 2026-04-09 Warnings Exact identifier application number: M020 Pro-Tect Sports Sunscreen SPF 20 MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE ABBE Laboratories, Inc. 35869e8d-8e48-4b22-8af3-6964fe8ac182 2026-04-09 Warnings Exact identifier application number: M020 Sunright 50 AVOBENZONE, HOMOSALATE, AND OCTINOXATE NSE Products, Inc. b1b76481-da23-427f-9b34-b987019fa532 2026-04-09 Warnings Exact identifier application number: M020 ThinkBaby SPF 30 ZINC OXIDE thinkOperations,LLC 06862b00-c937-41af-ab5d-cea34160d035 2026-04-09 Warnings Exact identifier application number: M020 Nutricentials Day Dream Protective HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE NSE Products, Inc. 4a376e93-85e8-40a5-8641-d3e3d11fdeea 2026-04-08 Warnings Exact identifier application number: M020 AGE20S UV MINERAL PRIMING SUNSCREEN ZINC OXIDE Aekyung Industrial Co., Ltd. 43c1f70b-0664-40be-e063-6394a90a2b48 2026-04-08 Warnings Exact identifier application number: M020 AGE20S SUNSCREEN DUO ZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Aekyung Industrial Co., Ltd. 4eef11cd-85a1-0e44-e063-6394a90a5d44 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE DEEP SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef430e8-cdc8-2897-e063-6394a90a3ac7 2026-04-08 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