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 191 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d37ec29-8d15-c716-e063-6394a90ae7092025-08-25WarningsExact identifier
application number: M020
RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN ADOREZINC OXIDERms organics LLC3d386cc9-e097-dacf-e063-6294a90a8fe22025-08-25WarningsExact identifier
application number: M020
Baby Bum Mineral 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d3a0d5c-a366-22fc-e063-6394a90a308b2025-08-25WarningsExact identifier
application number: M020
BOB Kids Sun Balm SPF 40ZINC OXIDE 23%SPF Ventures, LLCefa5c501-273c-5e97-e053-2995a90a865b2025-08-24WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCe4a2e6e4-5c35-4178-b341-65644233b7b82025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC57f91218-2477-4495-98e8-c512d823e1582025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc358745d-b9c0-4a9e-9a83-caffa04ea2e52025-08-22WarningsExact identifier
application number: M020
Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC050c2997-3ec0-4515-8a67-709b07a5010f2025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf3e27d-ab16-4f12-e063-6394a90a70e22025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf42e31-4e11-9b6d-e063-6294a90aa7412025-08-22WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1f619e-dd4e-ab62-e063-6294a90a10d42025-08-22WarningsExact identifier
application number: M020
Sun Bum Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cf8c55b-5203-3a96-e063-6294a90a4e9e2025-08-22WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenZINC OXIDESun Bum LLC369f449f-fb9d-5529-e063-6394a90ac3b22025-08-22WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM FOUNDATION SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb3cd01-8871-59a0-e063-6394a90ac0f72025-08-21WarningsExact identifier
application number: M020
Neutrogena Triple Age Repair Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCa6011835-cd2f-476f-9ec1-721f896483c52025-08-21WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC35fc2571-370c-42aa-986c-b1fa58658d862025-08-21WarningsExact identifier
application number: M020
Sun Bum 50 Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3ce436e8-bc22-b9d7-e063-6394a90a57c42025-08-21WarningsExact 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