FDA.reportPublic FDA data

Ultra Violette Future Screen Broad Spectrum SPF 50

Product NDC
84803-103
11-digit product format
848030103
Labeler code
84803
Product ID
84803-103_533c65d9-90f8-77af-e063-6394a90aefea
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Grace and Fire USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
ZINC OXIDE
Active strength
200 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 Future Screen Broad Spectrum SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
252fdc91-bbe2-58ec-e063-6294a90a5067Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
84803-103-15Ultra Violette Future Screen Broad Spectrum SPF 5015 mL in 1 BOTTLELOTION154
84803-103-21Ultra Violette Future Screen Broad Spectrum SPF 5020 mL in 1 BOTTLE, PUMPLOTION204
84803-103-50Ultra Violette Future Screen Broad Spectrum SPF 5050 mL in 1 BOTTLELOTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84803-103ULTRA VIOLETTE FUTURE SCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) LOTION [GRACE AND FIRE USA INC.]2Current NDC, 3 package rows20241202_252fdc91-bbe2-58ec-e063-6294a90a5067.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 69 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
application number: M020
Surfers BarrierZINC OXIDEAvasol LLCd6e2ac0a-3bf6-4d08-8647-6a23de2ac8572026-01-26WarningsExact identifier
application number: M020
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
application number: M020
Zenskin Watery Dew Nia-Cica SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREENZenskin Co. Ltd.49584899-d523-9677-e063-6394a90a14032026-01-26WarningsExact identifier
application number: M020
Caring mill sun serum with Vitamin C NiacinamideHOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONEFSA Store lnc.4931ee71-1088-1ac1-e063-6294a90ad82b2026-01-25WarningsExact identifier
application number: M020
Caring mill Mineral Eye CreamZINC OXIDEFSA STORE INC.4932ea19-28cc-b245-e063-6394a90ac7aa2026-01-25WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC2cee0413-d532-c192-e063-6294a90aa8232026-01-25WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.62e23503-7233-434a-91f0-092f10d2717d2026-01-24WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.030a20fb-4846-4a5c-9808-a399aac2ff0b2026-01-24WarningsExact identifier
application number: M020
Mimosa Lane SPF45OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENR&G Divergency LLC40f3b8ea-bfa5-4c66-9c79-c4408bda857a2026-01-24WarningsExact identifier
application number: M020
111 SKIN SUNSCREEN SPF 50ZINC OXIDEBentley Laboratories, LLCb1265797-71dd-4302-ab26-dbff6ccec8562026-01-23WarningsExact identifier
application number: M020
Mania Holic Sunscreen PackOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFirstmarket Co., ltd.b95a460c-1f7b-4193-b305-466e073af6402026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1cdbae71-441b-426d-99ee-c889d76af4522026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f4b5e0a-4578-4af3-b7d9-a19d4eb732e72026-01-23WarningsExact identifier
application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad SpectrumTITANIUM DIOXIDELG Household and Healthcare, Inc.c15ffd23-271d-458d-9048-9bc50331d5d72026-01-23WarningsExact identifier
application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.627e6ea5-016b-4ab6-a50c-aa9c27e5cca12026-01-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-103-158480301031515 mL in 1 BOTTLE (84803-103-15) 15 ml2024-12-01NoNoCurrent
84803-103-208480301032020 mL in 1 BOTTLE, PLASTIC (84803-103-20) 20 ml2024-12-01NoNoCurrent
84803-103-218480301032120 mL in 1 BOTTLE, PUMP20 mlHistorical
84803-103-508480301035050 mL in 1 BOTTLE (84803-103-50) 50 ml2024-12-01NoNoCurrent