Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk

Product NDC
84803-104
11-digit product format
848030104
Labeler code
84803
Product ID
84803-104_5a0e9ed0-8900-f1b7-e063-6394a90abe9f
Type
HUMAN OTC DRUG
Nonproprietary name
spf50
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Grace And Fire USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength
5; 3; 4.7 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
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE5 g/100g
AVOBENZONE3 g/100g
OCTOCRYLENE4.7 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
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2735ab0f-5eec-04c5-e063-6394a90aa60eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-104-01Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk7 g in 1 TUBEOINTMENT74
84803-104-02Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk15 g in 1 TUBEOINTMENT154
84803-104-02ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit15 g in 1 TUBEOINTMENT1 g in 153 g in 100g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84803-104ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM DUSK (SPF50) OINTMENT [GRACE AND FIRE USA INC.]2Current NDC, 2 package rows20250227_2735ab0f-5eec-04c5-e063-6394a90aa60e.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 172 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Light 280 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6b0b9204-f205-415b-bd16-1970958b8be72025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 240 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8c12a34c-f648-4b55-8265-d430c72ae2052025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 250 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 370 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8d4862e-2671-4b85-8338-f935e0d0194f2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 310 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8d53abee-73bc-4268-b08d-0c196ff4d8522025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 375 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1de296f5-276b-4e8f-8db2-78ea01965c4a2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 610 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.75543b93-8ed9-4c7b-9fcf-99745df5a1942025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 620 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.798eecb3-ff6e-46d1-9053-b40e9cd02e5c2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
application number: M020
SEKKISEI HERBAL UV DEFENSE gelAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKOS America, Inc.cb0faa3a-68f8-49c5-8c28-3338b1b27cd82025-10-31WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2c749a52-adaa-2609-e063-6294a90a8fc22025-10-30WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4260e410-d2d5-71b4-e063-6294a90a05b82025-10-30WarningsExact identifier
application number: M020
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
application number: M020
WEIGHTLESS PROTECTION SPF 30OCTINOXATE, ZINC OXIDE, OCTISALATEBotanical Science Technologiesde9a97b8-6633-4d71-e053-2995a90a5e8f2025-10-30WarningsExact identifier
application number: M020
Avinichi Noni Sol Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.9e534e32-efea-4dcf-adc1-18de3847ac042025-10-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-104-01848030104017 g in 1 TUBE (84803-104-01) 7 g2024-12-01NoNoCurrent
84803-104-028480301040215 g in 1 TUBE (84803-104-02) 15 g2024-12-01NoNoCurrent