FDA.reportPublic FDA data

Ultra Violette Supreme Screen Broad Spectrum SPF 50

Product NDC
84803-100
11-digit product format
848030100
Labeler code
84803
Product ID
84803-100_561cbb3d-11b5-8bce-e063-6294a90a871d
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
HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
70; 30; 50; 80 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 Supreme Screen Broad Spectrum SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE70 mg/mL
AVOBENZONE30 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal 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
24389324-19db-7eb5-e063-6394a90ad7fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-100-05Ultra Violette Supreme Screen Broad Spectrum SPF 505 mL in 1 TUBECREAM56
84803-100-15Ultra Violette Supreme Screen Broad Spectrum SPF 5015 mL in 1 TUBECREAM156
84803-100-20Ultra Violette Supreme Screen Broad Spectrum SPF 5020 mL in 1 BOTTLE, PLASTICCREAM206
84803-100-21Ultra Violette Supreme Screen Broad Spectrum SPF 5020 mL in 1 BOTTLE, PUMPCREAM206
84803-100-50Ultra Violette Supreme Screen Broad Spectrum SPF 5050 mL in 1 TUBECREAM506
84803-100-15Ultra Violette Mini MatesDuo Pack15 mL in 1 TUBECREAM1 mL in 158 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84803-100ULTRA VIOLETTE SUPREME SCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) CREAM [GRACE AND FIRE USA INC.]3Current NDC, 5 package rows20241202_24389324-19db-7eb5-e063-6394a90ad7fb.zip
84803-100ULTRA VIOLETTE MINI MATES DUO PACK (SPF 50) KIT [GRACE AND FIRE USA INC.]2Current NDC20241231_27e377c2-1e68-d4e2-e063-6394a90a2812.zip
84803-100ULTRA VIOLETTE MINI MATES DUO PACK (SPF 50) KIT [THERMO-PAK COMPANY, INC.]1Current NDC20241231_2a54ed65-12d5-8a96-e063-6394a90a6e02.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 21 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c09714-6137-7102-e063-6294a90a72a42026-06-08WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c13cc3-208e-ae7d-e063-6294a90a2a032026-06-08WarningsExact identifier
application number: M020
Innisfree Daily UV Defense Mineral SunscreenZINC OXIDE LOTIONInnisfree Corporation0e9cd3e5-cff8-7594-e063-6394a90aad902026-06-08WarningsExact identifier
application number: M020
Paulas Choice Lipscreen Broad Spectrum SPF 50OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENECosmetic Solutions LLC4c37e10c-3da5-4a48-b2c1-1b99ce9a02c12026-06-08WarningsExact identifier
application number: M020
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
application number: M020
Inflair Elevate SPF15 MoisturizerETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE HOMOSALATE BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Yapheon Health Industry Co., Ltd53a724e9-229e-eea4-e063-6294a90a7d5e2026-06-07WarningsExact identifier
application number: M020
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
application number: M020
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC538429b8-4f0e-e825-e063-6294a90a59052026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC5384da3c-4017-a3c1-e063-6294a90ae9a32026-06-05WarningsExact identifier
application number: M020
MEDULTIMA ADVENTURE SUNSCREENHOMOSALATE,OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.5368b2b3-fd80-9659-e063-6394a90a0ad32026-06-04WarningsExact identifier
application number: M020
WEN SixThirteen SPF 20 Dry Oil Intensive TreatmentOCTOCRYLENE, HOMOSALATE, ETHYLHEXYL METHOCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONEWEN by Chaz Dean536e6291-f5ca-37a4-e063-6394a90adfdb2026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
application number: M020
Glow Gloss Lip Balm SPF 40 Vanilla Soft ServeHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATESupergoop!26d2897f-46a7-52b2-e063-6394a90aed322026-06-04WarningsExact identifier
application number: M020
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
application number: M020
Abib No White Cast SPF Gift SetHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.537420bb-9fd8-0649-e063-6394a90aa8cf2026-06-04WarningsExact identifier
application number: M020
Airy sunstick smooting barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.f8203d54-cd3d-314d-e053-6394a90ac10d2026-06-04WarningsExact identifier
application number: M020
Play Everyday Sunscreen SPF 50 with Sunflower ExtractAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC0428eebc-4ffb-4981-b738-2c9ecf2a6a2e2026-06-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-100-05848030100055 mL in 1 TUBE (84803-100-05) 5 ml2024-12-01NoNoCurrent
84803-100-1084803010010100 mL in 1 BOTTLE (84803-100-10) 100 ml2026-07-08NoNoCurrent
84803-100-158480301001515 mL in 1 TUBE (84803-100-15) 15 ml2024-12-01NoNoCurrent
84803-100-208480301002020 mL in 1 BOTTLE, PLASTIC (84803-100-20) 20 ml2024-12-01NoNoCurrent
84803-100-218480301002120 mL in 1 BOTTLE, PUMP20 mlHistorical
84803-100-508480301005050 mL in 1 TUBE (84803-100-50) 50 ml2024-12-01NoNoCurrent