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 12 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISO AVOBENZONE, HOMOSALATE, OCTISALATE Koco Life LLC 568083ff-0da9-7f14-e063-6394a90a4301 2026-07-13 Warnings Exact identifier application number: M020 Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISO AVOBENZONE, HOMOSALATE, OCTISALATE Koco Life LLC 3cc62c97-70c5-17f7-e063-6394a90abe25 2026-07-13 Warnings Exact identifier application number: M020 Norwex Lip Glaze Broad Spectrum SPF 30 Rose ZINC OXIDE Norwex Usa, Inc. 565feded-8e25-e628-e063-6294a90aee48 2026-07-11 Warnings Exact identifier application number: M020 PoutScreen Lip Treatment Lemon Meringue AVOBENZONE, OCTINOXATE, OCTOCRYLENE NAKED SUNDAYS PTY LTD 563e3ab9-4ee2-279c-e063-6294a90a7cf1 2026-07-10 Warnings Exact identifier application number: M020 INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN ZINC OXIDE COSMAX USA, CORPORATION 5643a73d-757c-702d-e063-6294a90a2c12 2026-07-10 Warnings Exact identifier application number: M020 INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTE ZINC OXIDE COSMAX USA, CORPORATION 5643d655-e335-5643-e063-6394a90a483a 2026-07-10 Warnings Exact identifier application number: M020 MUSELY DAYCREAM SPF40 ZINC OXIDE COSMAX USA, CORPORATION 56443156-3edb-a643-e063-6394a90adf9f 2026-07-10 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE Cosmax USA, Corporation 56445f2d-8e5a-34eb-e063-6294a90ae26e 2026-07-10 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE Cosmax USA Corporation 5644854e-18d6-617d-e063-6294a90ab3e7 2026-07-10 Warnings Exact identifier application number: M020 VERSED DAILY SUNSCREEN SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE COSMAX USA, CORP 5644ca1e-9032-d3fb-e063-6394a90a961e 2026-07-10 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE Cosmax USA Corporation 5644855d-f864-e07b-e063-6394a90a5148 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 ZINC OXIDE COSMAX USA, CORP 5644d49f-08b9-e806-e063-6294a90a80f9 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRAL ZINC OXIDE COSMAX USA, CORP 564682e5-1051-9936-e063-6394a90abe1d 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRM ZINC OXIDE COSMAX USA, CORP 5646e069-5461-12c5-e063-6294a90abacb 2026-07-10 Warnings Exact identifier application number: M020 Protect Sport Sunscreen BROAD SPECTRUM SPF 30 Opal Day Spa 564704f2-b26a-d737-e063-6294a90aa6ff 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRAL ZINC OXIDE COSMAX USA, CORP 5647162a-610e-2789-e063-6294a90a7549 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVE ZINC OXIDE COSMAX USA, CORP 56472adb-572d-5a52-e063-6294a90a3cc3 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOL ZINC OXIDE COSMAX USA, CORP 56474782-beff-8437-e063-6294a90a8322 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACH ZINC OXIDE COSMAX USA, CORP 564749f3-e820-9003-e063-6294a90a0265 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRAL ZINC OXIDE COSMAX USA, CORP 56477f58-3878-81fa-e063-6294a90a87b7 2026-07-10 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