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 235 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen UnscentedZINC OXIDEEco Lips, Inc.febabad6-0bf2-a3f8-e053-6294a90a3aeb2025-01-08WarningsExact identifier
application number: M020
LESS EVERY TONE SPF 30ZINC OXIDEHappy Farm Botanicals, Inc.e91ded4b-987d-17a8-e053-2995a90adc2e2025-01-08WarningsExact identifier
application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact identifier
application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
application number: M020
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self TannerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.4d58de8e-875b-4b77-b0ef-b9d760aaced82025-01-07WarningsExact identifier
application number: M020
Pop Zinc SunscreenZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd2b29ddb2-5730-8a67-e063-6394a90ae4162025-01-07WarningsExact identifier
application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLCbbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c22025-01-07WarningsExact identifier
application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATEMedik8 Limited29071920-ba90-871a-e063-6294a90aee272025-01-06WarningsExact identifier
application number: M020
Dimples Bath Co - Sunstick New Kid On The BlockZINC OXIDEDimples Bath Co. LLC26f682f4-2440-f111-e063-6294a90ab4b72025-01-06WarningsExact identifier
application number: M020
Diaper Rash Cream Happy CheeksDIAPER RASH HAPPY CHEEKSDimples Bath Co. LLC26cef2eb-a133-11ec-e063-6394a90a0f082025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26fec959-c234-6692-e063-6394a90a66002025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26f85758-820f-3f73-e063-6294a90a289d2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Face MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0f0b56-233f-4c6a-e063-6394a90aea6f2025-01-06WarningsExact 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