FDA.reportPublic FDA data

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#

Effective, Related label table
EffectiveRelated label
2023-08-08092 Curad Petroleum-Free Lip Balm
2023-08-08092 Curad Petroleum-Free Lip Balm
2023-07-28092 Curad Petroleum-Free Lip Balm
2023-07-28092 Curad Petroleum-Free Lip Balm
2022-09-27092 Curad Petroleum-Free Lip Balm
2022-09-27092 Curad Petroleum-Free Lip Balm
2022-07-29092 Curad Petroleum-Free Lip Balm
2022-07-29092 Curad Petroleum-Free Lip Balm

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 278 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Sunscreen SPORT SPF 100AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWalmart Stores Inc.4fc58cea-082a-4535-9c51-8e7dedc15be32024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF100 SPORT Broad SpectrumAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWAL-MART STORES INC1ce4839b-f693-4653-8fe2-444df76eb83c2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50HOMOSALATE , OCTOCRYLENE, ZINC OXIDEWal-Mart Stores Inc0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c892024-10-16WarningsExact identifier
application number: M020
EQUATE Sunscreen BABY Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INCb2083cbd-ef19-4edc-9d7d-eca3452ee0ee2024-10-16WarningsExact identifier
application number: M020
Equate-Sunscreen Broad Spectrum SPF 50 ULTRAAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEWal-Mart Stores Incbbe06f23-0d0f-43ff-9d1b-37a99d9d62062024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY SPF 50 SPORT SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.c8c1c904-12f5-48e0-e053-2a95a90a9f752024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEBIG LOTS STORES, INC.e717ec77-8beb-645a-e053-2a95a90ac11b2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 50 Ultra Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBIG LOTS STORES, INC.f0dcb5d8-a3e5-4334-e053-2995a90a535a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE,BIG LOTS STORES, INC.c8aede4f-3d84-63d1-e053-2a95a90afb1a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sun DefenseAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBIG LOTS STORES, INC.db3ad809-d6c9-6c83-e053-2a95a90ac58b2024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.e4b70fdb-7548-175c-e053-2995a90adfe62024-10-16WarningsExact identifier
application number: M020
BIOLUMIN-C HEAT AGING PROTECTOR SPF50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.38d0b78b-bd8e-4cb0-925a-19adff550c192024-10-16WarningsExact identifier
application number: M020
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
application number: M020
Mula Maldives SPF 30 Moisturizing SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEMula Maldives PVT LTDf9be092f-8d53-4bb2-8363-81c003da42d62024-10-15WarningsExact identifier
application number: M020
Kroger Invisible Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf71ee1cd-e075-9ee9-e053-6394a90a8f9f2024-10-15WarningsExact identifier
application number: M020
Kroger Sunscreen Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76e12aa-9d98-5694-e053-6294a90a52562024-10-15WarningsExact identifier
application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATETHE KROGER COMPANYf0f350f4-b1b9-f4d3-e053-2995a90ac4592024-10-15WarningsExact identifier
application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76fe840-0da2-a903-e053-6294a90a05ee2024-10-15WarningsExact identifier
application number: M020
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact 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