FDA.reportPublic FDA data

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 49 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sunscreen CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEJiangsu Senwo Medical Technology Co., Ltd.4e615757-76b1-8f34-e063-6394a90a280a2026-04-01WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67b76e-b791-4e26-e063-6294a90aa9912026-04-01WarningsExact identifier
application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67e89b-a7be-a540-e063-6294a90a6d8f2026-04-01WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationcad3a446-36a8-4146-81b5-1cc8d65abf142026-04-01WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.8de4ec46-f60a-4c51-a16e-9140150e21622026-04-01WarningsExact identifier
application number: M020
ChapStick Moisturizer Cool Mint SPF 15SPF 15 LIP PROTECTANTSuave Brands Co., LLC42f50497-ded1-6863-e063-6294a90a39c82026-03-31WarningsExact identifier
application number: M020
Purito Sunday Adventure Sunscreen SPF 50, 50 mLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHinaturebf16f535-97fc-4fd8-9310-8b6bbc82baae2026-03-31WarningsExact identifier
application number: M020
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
application number: M020
Badger SPF 30 Face Mineral SunscreenZINC OXIDEW.S. Badger Company, Inc.14a9b605-f1f0-00e5-e063-6394a90a5a512026-03-31WarningsExact identifier
application number: M020
Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades)OCTINOXATE AND ZINC OXIDENoxell Corporation38bba282-b4f7-4374-8732-419400b1cc502026-03-31WarningsExact identifier
application number: M020
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
application number: M020
ageLOC Tru Face Radiant DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.3e9a0b39-4351-41df-81b2-88c1c15c0db22026-03-31WarningsExact identifier
application number: M020
Sunright Solar Screen Mineral Face SunscreenZINC OXIDENSE Products, Inc.93a32040-3a47-4d6f-baa1-5a4595bef4102026-03-31WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc28f500e2-41d1-4747-8f26-3f6f8cc1b5832026-03-30WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENESICOS ET CIEdd448b7a-2554-4dfc-9eb3-ec3486ec61972026-03-30WarningsExact identifier
application number: M020
ANUA MINERAL WEIGHTLESS FINISH SUNSCREENZINC OXIDEThefounders4e37d291-84fb-252a-e063-6294a90acd1f2026-03-30WarningsExact identifier
application number: M020
Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDETHE AVON COMPANY4e43bea2-247d-fe11-e063-6294a90a33a32026-03-30WarningsExact identifier
application number: M020
Abib Quick sunstick Protection barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.1a2ab632-643f-1aa9-e063-6394a90a0c052026-03-30WarningsExact identifier
application number: M020
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4514490b-f348-4526-e063-6294a90ad5052026-03-30WarningsExact identifier
application number: M020
ChapStick Moisturizer Black Cherry SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC42f40978-51ca-f448-e063-6294a90acf312026-03-30WarningsExact 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