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 182 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vertra Pearl White Face Stick SPF 50 PADIMATE O, TITANIUM DIOXIDE Eai-jr 286, Inc b69a75e0-8724-35ae-e053-2a95a90a5f34 2025-10-07 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE EAI-JR 286, Inc. b9ea12e8-6ed9-d805-e053-2a95a90aa107 2025-10-07 Warnings Exact identifier application number: M020 SPF50 Sunscreen SUNSCREEN KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD b3cde609-7d62-2ac7-e053-2a95a90a26b3 2025-10-07 Exact identifier application number: M020 Summer Face Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC fe256ff4-cb92-4262-8ab9-7cc912e0af22 2025-10-06 Warnings Exact identifier application number: M020 Sun Veil Broad Spectrum SPF50 ZINC OXIDE MONAT GLOBAL CORP 3ba28de7-74a2-5cde-e063-6394a90add26 2025-10-06 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE Toshiki Pigment Co., Ltd. b9eba15f-493a-43c9-e053-2995a90a0451 2025-10-06 Warnings Exact identifier application number: M020 Apple Lip Balm with Aloe Vera BROAD SPECTRUM SPF 15 SUNSCREEN LIP BALM Durvet, Inc. 6dcbb2cd-e690-4970-8cf1-08ca539d3602 2025-10-06 Warnings Exact identifier application number: M020 PURE SOL SPF 50 Daily Moisturizer ZINC OXIDE Brand 2022b LLC 4051506c-fc13-cd22-e063-6394a90a977e 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer) ZINC OXIDE Brand 2022b LLC 4051ced5-85cf-6211-e063-6394a90a09fc 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen ZINC OXIDE Brand 2022b LLC 4051d241-6890-2b06-e063-6294a90aa09d 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 37 Tinted Moisturizer ZINC OXIDE TITANIUM DIOXIDE Brand 2022b LLC 4052c4e4-2105-80c0-e063-6294a90af41d 2025-10-04 Warnings Exact identifier application number: M020 PLAY Antioxidant Body Mist SPF 50 - Vanilla Orchid AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7a9722-d211-e861-e063-6294a90a6cdc 2025-10-02 Warnings Exact identifier application number: M020 Kids Mineral Sunscreen SPF50 SUNSCREEN Hello Bello 01cc554b-9241-d891-e063-6394a90a8450 2025-10-02 Warnings Exact identifier application number: M020 HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB SUNSCREEN SPF 50 IHerb, LLC 3cab1598-5ef3-df73-e063-6394a90ab1e2 2025-10-01 Warnings Exact identifier application number: M020 Moisturizing Rich Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC 36c3ba26-ca25-7498-e063-6294a90a47fc 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 Shade 1 ZINC OXIDE Dime Beauty Co, LLC 07104cbf-0446-a053-e063-6394a90ab41f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 ZINC OXIDE Dime Beauty Co, LLC 07503a1f-d530-e3bb-e063-6294a90a8ae3 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC e38deed3-e1e2-0b1d-e053-2a95a90a547f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC f2a59fa4-f19c-a15f-e053-2a95a90a6ace 2025-10-01 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414b88ca-a3df-5e42-e063-6294a90a69ba 2025-10-01 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