FDA.reportPublic FDA data

Ultra Violette Vibrant Screen Broad Spectrum SPF 50

Product NDC
84803-102
11-digit product format
848030102
Labeler code
84803
Product ID
84803-102_533ca427-a0e4-cd7f-e063-6294a90a9c10
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
Grace and Fire USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE
Active strength
30; 80; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
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 Vibrant Screen Broad Spectrum SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTOCRYLENE80 mg/mL
OCTISALATE50 mg/mL
HOMOSALATE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2633a289-b3b2-b614-e063-6294a90ad214Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-102-00Ultra Violette Vibrant Screen Broad Spectrum SPF 50100 mL in 1 BOTTLECREAM1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84803-102ULTRA VIOLETTE VIBRANT SCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [GRACE AND FIRE USA INC.]2Current NDC, 1 package rows20241220_2633a289-b3b2-b614-e063-6294a90ad214.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 176 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby RoseZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9d9419-a7e1-bc42-e063-6394a90af5112025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e8af968-77d5-1dcd-e063-6394a90a66992025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy ShellZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9e95c3-4ac8-5962-e063-6294a90a0c022025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 TerracottaZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9dd230-b087-cda7-e063-6394a90ae0842025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9b0642-53ed-ec94-e063-6394a90aec3d2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d977158-8b5d-66ac-e063-6294a90a4d5c2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0eae4b71-60be-9715-e063-6294a90af4632025-10-20WarningsExact identifier
application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum SunscreenZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.9ed70230-980c-474c-9f72-a6be0f3551242025-10-20WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC419c8718-6b9e-3df7-e063-6294a90a1e3b2025-10-20WarningsExact identifier
application number: M020
Sonni SunDay SerumZINC OXIDESonni419d4ada-fe9b-b774-e063-6394a90a3d092025-10-20WarningsExact identifier
application number: M020
Lip Clear Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.66f84e56-4a5d-4b71-8bd3-79961e7bf4fe2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Strawberry Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.2cafc97f-4cd3-4755-b394-3802c28d4ed52025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Tangerine Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.8a00194e-9e28-4257-82e5-59bc44f7897d2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
application number: M020
Terez Honor Hydro SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEWYCREAM INC418d054b-436f-6aa3-e063-6294a90a0f562025-10-19WarningsExact identifier
application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc5a67314-e5b2-4dd6-94e9-39c2f286c3462025-10-17WarningsExact identifier
application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREENZINC OXIDELion Pose Inc.0310407b-fb74-aa8b-e063-6294a90ad8412025-10-17WarningsExact identifier
application number: M020
Thrive Daily Defense Sunscreen Balm SPF30ZINC OXIDEThrive Natural Care, Inc1266bd05-1971-a7f0-e063-6394a90a089c2025-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-102-0084803010200100 mL in 1 BOTTLE (84803-102-00) 100 ml2024-12-01NoNoCurrent