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 184 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVE AVOBENZONE, HOMOSALATE, OCTISALATE MDSolarSciences 3fa810b0-0211-f2a7-e063-6294a90a0b72 2025-09-25 Warnings Exact identifier application number: M020 SUN BUFF SPF 30 MINERAL SUNSCREEN ZINC OXIDE/TITANIUM DIOXIDE SPF Ventures, LLC 3f874062-ebab-8993-e063-6294a90abfc5 2025-09-24 Warnings Exact identifier application number: M020 HygieneLab Face and Body Mineral Sunscreen SPF 50 ZINC OXIDE HYGIENELAB, INC 7db103da-b434-433a-a18f-a727165640c0 2025-09-24 Warnings Exact identifier application number: M020 Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE Space Brands Limited 0e2c9ffb-036d-49c5-abdb-2ee8888df318 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint DG6 ZINC OXIDE PUR Minerals 3f8e97a7-2023-ba9c-e063-6294a90ac9c9 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint TN7 ZINC OXIDE PUR Minerals 3f0717c7-f43f-e3b1-e063-6394a90a74dd 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint TN2 ZINC OXIDE PUR Minerals 3f06ed2f-f43f-53d4-e063-6294a90af0dd 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint MN4 ZINC OXIDE PUR Minerals 3f06f618-f7b2-53d0-e063-6294a90a829c 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint MN3 ZINC OXIDE PUR Minerals 3f06df49-5ed2-44ca-e063-6294a90a1fda 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint LN2 ZINC OXIDE PUR Minerals 3f069dfe-289d-8d3b-e063-6394a90a0496 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint LG3 ZINC OXIDE PUR Minerals 3f06ec3e-fc15-9f7b-e063-6394a90a0733 2025-09-24 Warnings Exact identifier application number: M020 Volition Prismatic Luminizing Shield ZINC OXIDE Volition 1a633c24-b9d9-4732-e063-6294a90af4c0 2025-09-24 Warnings Exact identifier application number: M020 Alleyoop Sunsational Broad Spectrum ZINC OXIDE NewAlley Innovations Inc 248419c4-8044-402c-e063-6394a90a00f8 2025-09-24 Warnings Exact identifier application number: M020 Aloe Up SPF 30 coco-mango mist AVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0% Aloe Up f7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e92 2025-09-24 Warnings Exact identifier application number: M020 pavise Dynamic Age Defense ZINC OXIDE B.A.I BIOSCIENCES, INC f4e9f95c-6b1e-d5f7-e053-2a95a90a93ce 2025-09-24 Warnings Exact identifier application number: M020 Aloe Up SPF 50 coco-mango mist AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0% Aloe Up d535b711-c54e-4447-9907-ca9d829d1319 2025-09-24 Warnings Exact identifier application number: M020 ESPOIR WATER SPLASH SUN SERUM HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE ESPOIR Corporation 1c4e7ba2-05e8-f949-e063-6394a90a699d 2025-09-23 Warnings Exact identifier application number: M020 Banana Boat ZINC OXIDE Edgewell Personal Care Brands LLC 1d11c3d0-5f4e-0ed0-e063-6294a90abc75 2025-09-23 Warnings Exact identifier application number: M020 Dewscreen Daily Hydrator and Primer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7c84e3-0e4f-b7e9-e063-6294a90a1295 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15d8574d-94bb-4842-e063-6394a90a15e6 2025-09-23 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