FDA.reportPublic FDA data

Sunsei SPF 45 Sunscreen

Product NDC
85791-4531
11-digit product format
857914531
Labeler code
85791
Product ID
85791-4531_4c9e0316-7c08-d8a8-e063-6294a90a895b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Shimoda Prime Products, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-15
Substance
ZINC OXIDE
Active strength
25 g/100mL
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
Sunsei SPF 45 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE25 g/100mL

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
3d48e3e2-18c7-e004-e063-6294a90af4f2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85791-4531-1Sunsei SPF 45 Sunscreen89 mL in 1 TUBELIQUID892

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 79 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdf292da7d-ffd2-41c3-9a64-619aab19ff182026-01-15WarningsExact identifier
application number: M020
Multivit Sun ProtectorTITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltdabdb560d-29be-41dc-ad23-54ea571acb142026-01-15WarningsExact identifier
application number: M020
BeautyBarrierZINC OXIDENAKED SUNDAYS PTY LTD45740afa-230d-4dd5-e063-6394a90a102f2026-01-15WarningsExact identifier
application number: M020
Glow This WayOCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATEKoco Life LLC4619cf96-987a-3e88-e063-6294a90afbe92026-01-15WarningsExact identifier
application number: M020
Reef safe lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.486930f2-026b-14b4-e063-6394a90aa0312026-01-15WarningsExact identifier
application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC316bf6f8-7d30-2560-e063-6294a90afb8a2026-01-15WarningsExact identifier
application number: M020
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier
application number: M020
Bali Body Sheer Glow Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd4872793c-a7c0-1b65-e063-6394a90a8b3a2026-01-15WarningsExact identifier
application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEVolition Beauty2631de4b-66e3-0547-e063-6394a90a822c2026-01-15WarningsExact identifier
application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30ZINC OXIDESKINN COSMETICS, LLC350ed168-ab3b-f314-e063-6394a90a8bbf2026-01-15WarningsExact identifier
application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEStriVectin Operating Company, Inc.4873a262-a19b-555e-e063-6394a90a182a2026-01-15WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLCe843bb6b-257f-4425-95bc-41774e032a092026-01-15WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLC1e18f1dd-a4e4-455a-9699-5634b95596782026-01-15WarningsExact identifier
application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company485c345f-0928-fa1a-e063-6294a90aa8562026-01-14WarningsExact identifier
application number: M020
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC19af4441-31b2-72db-e063-6394a90a813c2026-01-14WarningsExact identifier
application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30ZINC OXIDESqween LLC9c3cf35b-4bde-46e3-8abd-5f4d1ad6e4862026-01-14WarningsExact identifier
application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES DRUIDE INC0799ac38-9a41-6579-e063-6394a90ac4b62026-01-14WarningsExact identifier
application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC0b412e24-baf6-e68e-e063-6394a90a5f492026-01-14WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIfc89d1b5-1ffe-4f06-8c5c-31f2eb0b56412026-01-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85791-4531-18579145310189 mL in 1 TUBE (85791-4531-1) 89 ml2026-03-15NoNoCurrent