FDA.reportPublic FDA data

Anti Aging Lip Balm Pot SPF 15

Product NDC
84378-103
11-digit product format
843780103
Labeler code
84378
Product ID
84378-103_56331742-cd4b-67d5-e063-6294a90aa19d
Type
HUMAN OTC DRUG
Nonproprietary name
Lip Balm
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Epicuren Disocovery
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-07
Substance
AVOBENZONE; OCTISALATE; OCTINOXATE
Active strength
3; 4.5; 7.5 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Anti Aging Lip Balm Pot SPF 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
OCTISALATE4.5 g/100g
OCTINOXATE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4097e28a-ed11-e16a-e063-6294a90a5e9bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84378-103-07Anti Aging Lip Balm Pot SPF 157 g in 1 JAROINTMENT71

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 233 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zealios SPF LipGuardOCTISALATE AND AVOBENZONEPersonal Best Products Inc. dba Zealios3a07822b-a7c9-40af-a8f7-bea591c7a49b2025-01-13WarningsExact identifier
application number: M020
SPF-30 BBZINC OXIDEZION HEALTH66d33d8c-8900-4698-98fe-0dedafe674d82025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
application number: M020
Skin Apeel Ageless Defense SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.c3bbe779-b012-4f19-8b90-2c7a4dd886172025-01-13WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEKATE SOMERVILLE SKINCARE LLC1a33cb41-440a-41cb-9832-24255bfa2b7c2025-01-12WarningsExact identifier
application number: M020
ALLSWELL MINERAL SUNSCREEN SPF 30ZINC OXIDEStream2Sea, LLC03bee988-d6e3-4290-a926-9c5366649cba2025-01-12WarningsExact identifier
application number: M020
Baby Donna SHeer SPF Sunscreen StickZINC OXIDEStream2Sea, LLCa1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe2025-01-12WarningsExact identifier
application number: M020
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b5aebed-49f6-7bb8-e063-6294a90a85212025-01-10WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Drops Face SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b5c69e4-2819-94ef-e063-6394a90a68e72025-01-10WarningsExact identifier
application number: M020
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
application number: M020
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.b8e4c11a-4b4f-4e36-a75e-0a73913113d52025-01-10WarningsExact identifier
application number: M020
Correct and Protect Serum Broad Spectrum SPF 45ZINC OXIDEMurad, LLC60c62108-6806-4722-a44b-f1c300d59c1e2025-01-10WarningsExact identifier
application number: M020
Multi Vitamin Clear Coat Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLCe023c874-c89d-4bd0-a0b9-a8161c2614572025-01-10WarningsExact identifier
application number: M020
CoTZ BabyZINC OXIDEFallien Cosmeceuticals, LTD17cc12c7-5af8-413f-b205-31ac150583e22025-01-09WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.2b3bdbe1-ede9-cd60-e063-6394a90ab2f32025-01-09WarningsExact identifier
application number: M020
JAFRA ROYAL REVITALIZE 4 TUBE SETAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca982025-01-09WarningsExact identifier
application number: M020
glo SKIN BEAUTY Moisturizing Tint SPF 30GLO SKIN BEAUTY MOISTURIZING TINT SPF 30Hayden Caleel LLC2b464a70-8f40-3148-e063-6394a90ac18c2025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd65d15a6-0a32-1203-e053-2995a90aa6c52025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd5fb3632-24da-2c7a-e053-2a95a90a50812025-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84378-103-07843780103077 g in 1 JAR (84378-103-07) 7 g2025-10-07NoNoCurrent