FDA.reportPublic FDA data

ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen

Product NDC
84803-116
11-digit product format
848030116
Labeler code
84803
Product ID
84803-116_56ad0dce-410f-9d78-e063-6294a90a1c3e
Type
HUMAN OTC DRUG
Nonproprietary name
bemotrizinol, octocrylene, zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Grace and Fire USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-09
Substance
BEMOTRIZINOL; OCTOCRYLENE; ZINC OXIDE
Active strength
.3; .6; 1 g/10mL; g/10mL; g/10mL
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 Unblock Screen SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEMOTRIZINOL.3 g/10mL
OCTOCRYLENE.6 g/10mL
ZINC OXIDE1 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PWZ1720CBHInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56ad0dce-410e-9d78-e063-6294a90a1c3eAvailable on FDA.report

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 46 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arizona Sun Kids Sunscreen SPF 30SUNSCREENArizona Sun Products10f60367-6681-a589-e063-6394a90a6bb82026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products115b4d4c-51f1-ad62-e063-6294a90a3e532026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e48195-7bae-2422-e063-6394a90a261c2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e276e4-81f1-9429-e063-6394a90a800d2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 8SUNSCREENArizona Sun Products106a9608-f7a4-0f8c-e063-6394a90a26ab2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15LIP BALMArizona Sun Products11fced72-39f9-f3a3-e063-6294a90a8b732026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fc2a82-260c-7cd3-e063-6394a90af2c12026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd9aa5-dbd6-e5a7-e063-6394a90a3eac2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fc93a7-f5be-965d-e063-6394a90ab3352026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd1661-1b91-b65b-e063-6394a90af89b2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Lipkist Lip Balm SPF 15LIP BALMArizona Sun Products11fbcb81-2735-53c8-e063-6394a90ab0fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd8776-99f8-e5a4-e063-6394a90a20332026-04-09WarningsExact identifier
application number: M020
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
application number: M020
Pro-Tect Sports Sunscreen SPF 20MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEABBE Laboratories, Inc.35869e8d-8e48-4b22-8af3-6964fe8ac1822026-04-09WarningsExact identifier
application number: M020
Sunright 50AVOBENZONE, HOMOSALATE, AND OCTINOXATENSE Products, Inc.b1b76481-da23-427f-9b34-b987019fa5322026-04-09WarningsExact identifier
application number: M020
ThinkBaby SPF 30ZINC OXIDEthinkOperations,LLC06862b00-c937-41af-ab5d-cea34160d0352026-04-09WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.4a376e93-85e8-40a5-8641-d3e3d11fdeea2026-04-08WarningsExact identifier
application number: M020
AGE20S UV MINERAL PRIMING SUNSCREENZINC OXIDEAekyung Industrial Co., Ltd.43c1f70b-0664-40be-e063-6394a90a2b482026-04-08WarningsExact identifier
application number: M020
AGE20S SUNSCREEN DUOZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAekyung Industrial Co., Ltd.4eef11cd-85a1-0e44-e063-6394a90a5d442026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-116-05848030116051 TUBE in 1 CARTON (84803-116-05) / 5 mL in 1 TUBE1 tube2026-08-09NoNoCurrent
84803-116-50848030116501 JAR in 1 CARTON (84803-116-50) / 50 mL in 1 JAR1 jar2026-08-09NoNoCurrent