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 149 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
application number: M020
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
application number: M020
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be70d5-aefe-fd6f-e063-6394a90ac4362025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be17ce-c3a7-fd59-e063-6394a90ad11d2025-12-08Exact identifier
application number: M020
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
application number: M020
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
application number: M020
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
application number: M020
Inblair Elevate SPF15 MoisturizerINBLAIR ELEVATE SPF15 MOISTURIZERGuangzhou Fantesy Biotechnology Co.,Ltd4567d413-d8cc-677b-e063-6294a90a1a422025-12-07WarningsExact identifier
application number: M020
HANCHOBIT Radiant Pink Tone Up Sun CreamTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.45685047-166d-8af5-e063-6294a90aa7be2025-12-07WarningsExact identifier
application number: M020
EELHOE Moisturiser Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.454004c9-07fa-64ad-e063-6394a90a0c8a2025-12-06WarningsExact identifier
application number: M020
OUHOE Daily Exposure Lightweight SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.454301b6-21a6-6153-e063-6294a90a13662025-12-06WarningsExact identifier
application number: M020
OUHOE Cotton Soft Sun StickTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4543a43e-acf7-6759-e063-6394a90a2f532025-12-06WarningsExact identifier
application number: M020
OUHOE Centella Daily SunTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4544f3a3-8c52-ea54-e063-6394a90a7a9c2025-12-06WarningsExact identifier
application number: M020
EELHOE All Day Light Sunscreen MistTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45323ca3-c706-dcb5-e063-6394a90a96f72025-12-05WarningsExact identifier
application number: M020
EELHOE Airy SunstickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45328c13-31ae-3bd2-e063-6394a90a814f2025-12-05WarningsExact 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