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 221 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lip Balm SPF15 Vanilla LIP BALM SPF15 VANILLA LS Promotions Inc 312d0dc5-3933-ecfe-e063-6294a90a9b66 2025-03-25 Warnings Exact identifier application number: M020 Lip Balm SPF15 Blueberry Cobbler LIP BALM SPF15 BLUEBERRY COBBLER LS Promotions Inc 312fb7b0-86a9-ca88-e063-6294a90a76c8 2025-03-25 Warnings Exact identifier application number: M020 Lip Balm SPF15 Peppermint LIP BALM SPF15 PEPPERMINT LS Promotions Inc 3130be1c-0167-2389-e063-6394a90aa61d 2025-03-25 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 30 SUNSCREEN SPF 30 OL PHARMA TECH LLC. (Drs. Pharmacy) 052dea5d-a775-8dc2-e063-6294a90a4f19 2025-03-25 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 50 SUNSCREEN SPF 50 OL PHARMA TECH LLC. (Drs. Pharmacy) 0def5c19-b088-2ffb-e063-6394a90aa109 2025-03-25 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 70 SUNSCREEN SPF 70 OL PHARMA TECH LLC. (Drs. Pharmacy) 0def6fa1-b028-fad5-e063-6394a90a1913 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84521 ZINC OXIDE e.l.f. Cosmetics, Inc. 31329426-d952-ee5d-e063-6294a90a55f4 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84520 ZINC OXIDE e.l.f. Cosmetics, Inc. 31328845-9a67-d237-e063-6294a90a2a7f 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84519 ZINC OXIDE e.l.f. Cosmetics, Inc. 31327ea3-affd-ca13-e063-6294a90a7238 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84517 ZINC OXIDE e.l.f. Cosmetics, Inc. 3132641a-e593-a9e8-e063-6294a90acc80 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84518 ZINC OXIDE e.l.f. Cosmetics, Inc. 3132669c-e104-ae1e-e063-6294a90aee7f 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84514 ZINC OXIDE e.l.f. Cosmetics, Inc. 31324410-3142-89e1-e063-6294a90a22ee 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84515 ZINC OXIDE e.l.f. Cosmetics, Inc. 31324ff6-a091-a51b-e063-6294a90a1dbb 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84513 ZINC OXIDE e.l.f. Cosmetics, Inc. 3131d155-4c23-db51-e063-6294a90a0019 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50-84505 ZINC OXIDE e.l.f. Cosmetics, Inc. 312d171d-b057-96d1-e063-6394a90ac429 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84511 ZINC OXIDE e.l.f. Cosmetics, Inc. 313175f3-e42a-b2a7-e063-6294a90abcb7 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84510 ZINC OXIDE e.l.f. Cosmetics, Inc. 3131696a-a37a-908b-e063-6294a90a5e95 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84512 ZINC OXIDE e.l.f. Cosmetics, Inc. 31318380-79fe-c0e0-e063-6294a90af4fc 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84508 ZINC OXIDE e.l.f. Cosmetics, Inc. 3131512e-f97b-718e-e063-6294a90aa3c1 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84509 ZINC OXIDE e.l.f. Cosmetics, Inc. 313147bc-0095-7cbd-e063-6294a90a7d28 2025-03-25 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