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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct53329-092IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53329-09253329-092-83IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…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
IngredientStrength
OCTINOXATE2 g/100g
OXYBENZONE4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6125d98a-6fc7-4f50-924e-3b1f7ee951f4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-092-83Petroleum-Free Lip Balm4.2 g in 1 CONTAINERLIPSTICK4.28
53329-092-83Petroleum-Free Lip Balm1 in 1 BOXLIPSTICK18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VPETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-092PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 2 package rows20241204_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 217 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32b5a19e-86d4-5ee1-e063-6394a90a12e22025-04-11WarningsExact identifier
application number: M020
LERINN ZINCPURE SUNMILK SPF 50ZINC OXIDESerrina Lin Skincare Inc32717b49-729c-a229-e063-6394a90a18fb2025-04-10WarningsExact identifier
application number: M020
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
application number: M020
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTOCRYLENE, ZINC OXIDE, OCTISALATESunstation USA LLC6007c125-f28a-45e5-b8f1-490ee04b78112025-04-09WarningsExact identifier
application number: M020
Pacifica Sun Dreams Illuminating SPF FoamHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPacifica Beauty, LLC2e0cb105-75c3-8032-e063-6394a90ab5022025-04-09WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANELG H&H CO., LTD.284cadf1-deb9-4f3d-e063-6394a90ab1222025-04-09WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDaa79b1a4-6b33-47c9-b55e-b813d9b222652025-04-09WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc OnlyZINC OXIDESPF Ventures, LLC3240cbe5-bfc8-17f7-e063-6394a90a1b982025-04-08WarningsExact identifier
application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral FaceZINC OXIDELG HOUSEHOLD & HEALTH CARE LTD.2eeac795-b74e-b3a3-e063-6294a90abf522025-04-08WarningsExact identifier
application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2ee9f271-b508-2304-e063-6294a90a37522025-04-08WarningsExact identifier
application number: M020
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarinsa43d0d4f-94de-4c4b-a17a-63a819d5d2932025-04-07WarningsExact identifier
application number: M020
Gangnam Glow Sunscreen 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30cc2e35-f752-8285-e063-6294a90afbf52025-04-07WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.26f8dc88-2096-4fa1-81ae-ea92fe1f353d2025-04-07WarningsExact identifier
application number: M020
Vacation Instant BrowningAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.13028f61-3f62-22cc-e063-6394a90a6bf12025-04-04WarningsExact identifier
application number: M020
LBri Pure n Natural SPF 30ZINC OXIDEL'BRI HEALTH & BEAUTY8350791d-5cf2-4358-9f85-9384d35be9f42025-04-03WarningsExact identifier
application number: M020
SHEER MINERAL SUNSCREENZINC OXIDEPlant Devas Inc. dba evanhealyf620ef44-f30c-4cc9-bc82-28dc4a47a8da2025-04-02WarningsExact identifier
application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD0116cffa-3415-746b-e063-6394a90ab3b32025-04-01WarningsExact identifier
application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD04293280-e74a-f293-e063-6394a90a06f62025-04-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-092-83533290092831 CONTAINER in 1 BOX (53329-092-83) / 4.2 g in 1 CONTAINER1 container2010-04-010000-00-00NoNoCurrent