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 117 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Total Eye 3-In-1 Renewal Therapy SPF 35 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c 2025-12-16 Warnings Exact identifier application number: M020 Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32 ZINC OXIDE Onekind.25 c11197f4-cee0-04b3-e053-2995a90a1ba8 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium Deep ZINC OXIDE Crunchi, LLC. 69618265-2ebb-4cdc-a28f-e36c07fe5b8f 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium ZINC OXIDE Crunchi, LLC. 23248bc3-1b82-443a-b38a-df7f0efb5d2a 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light ZINC OXIDE Crunchi, LLC. cf4039f5-00ee-4227-a3dc-61995c800135 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Body Sunscreen SPF 30 ZINC OXIDE Crunchi, LLC. 227f5a41-8c3c-492d-947f-e2b046208bca 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light Medium ZINC OXIDE Crunchi, LLC. 5b3f2766-065b-4817-a5ff-bd1c7882bfc9 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Daily Facial Sunscreen SPF 30 ZINC OXIDE Cruchi, LLC. 4f3bcfa0-e43e-4284-afaa-6488ddd749f0 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543a22c-34d5-e572-e063-6394a90ad579 2025-12-15 Exact identifier application number: M020 Stellar Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6488c-d216-8742-e063-6394a90a16e2 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb8ee19-81b2-daed-e063-6394a90a0fb3 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6cfd4-fa4a-d1d9-e063-6394a90a8e43 2025-12-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 35442ac0-c361-e08f-e063-6294a90a5cb2 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543e85d-9bc7-b8ed-e063-6294a90ae7d3 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bc8593d-fc6c-04aa-e063-6394a90a6d56 2025-12-15 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE MANTRA WELLNESS SPA 338855fd-3008-44d9-e063-6294a90a5e07 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE MANTRA WELLNESS SPA 33898415-4ee6-a384-e063-6394a90ae8e1 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Mantra Wellness Spa 3389b0a3-40f9-b411-e063-6394a90a9959 2025-12-15 Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE Mantra Wellness Spa 338a11fb-24c6-8a0b-e063-6294a90a761e 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Mantra Wellness Spa 338aa5a2-29e3-fe0e-e063-6294a90a18fd 2025-12-15 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