FDA.reportPublic FDA data

Anti-Aging Lip Balm SPF 15

Product NDC
84378-102
11-digit product format
843780102
Labeler code
84378
Product ID
84378-102_5696ed0b-30e1-9f3f-e063-6394a90a8f4c
Type
HUMAN OTC DRUG
Nonproprietary name
Lip Balm
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Epicuren Discovery
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-19
Substance
OCTINOXATE; AVOBENZONE; OCTISALATE
Active strength
7.5; 3; 4.5 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 SPF 15
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cbd0550-b6e5-3e86-e063-6394a90ac07fAvailable 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
84378-102-07Anti-Aging Lip Balm SPF 157 g in 1 TUBEOINTMENT71

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 189 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3dd7b0af-dc37-1701-e063-6294a90a65c32025-09-02WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7e7ef4-c3ac-4c26-e063-6394a90a9e422025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.3a7db6f4-66fd-4473-e063-6394a90a886e2025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7eb413-ff49-711d-e063-6394a90ad6dc2025-09-01WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3db1cf3e-0640-6821-e063-6294a90a70362025-08-31WarningsExact identifier
application number: M020
Purpose Dual Treatment SPF 10OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%Elysium Consumer Healthcare LLC3d7fe711-a671-df30-e063-6394a90afbbf2025-08-29WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30ZINC OXIDEGood Weather Inc.3d83aaa5-0e4e-928a-e063-6294a90a24da2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3abd12f4-cbe3-4dd7-e063-6394a90a50a22025-08-28WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d49b054-9f49-17d1-e063-6294a90a757a2025-08-28WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
application number: M020
Jack Black Double DutyAVOBENZONE OCTOCRYLENEJack Black L.L.C.36d81d6d-4f9b-692d-e063-6294a90ad5592025-08-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84378-102-07843780102077 g in 1 TUBE (84378-102-07) 7 g2025-08-19NoNoCurrent