FDA.reportPublic FDA data

BETA-GLUCAN MILD SUNSCREEN

Product NDC
83403-101
11-digit product format
834030101
Labeler code
83403
Product ID
83403-101_47d6ad8b-1082-ee21-e063-6294a90a0e63
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
IUNIK Co., Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-07
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
10.08; 5.61 g/100mL; 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
BETA-GLUCAN MILD SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10.08 g/100mL
TITANIUM DIOXIDE5.61 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47d6ad8b-1081-ee21-e063-6294a90a0e63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83403-101-01BETA-GLUCAN MILD SUNSCREEN60 mL in 1 TUBELOTION601
83403-101-02BETA-GLUCAN MILD SUNSCREEN1 in 1 BOXLOTION11

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 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulta Beauty Tinted Moisturizer Cream Spf 24 MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc0ff10-fb2f-e637-e053-6294a90a0c292024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 DeepAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984c64f-eaac-ecb6-e063-6394a90aeb122024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 TanAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984a014-a56f-753b-e063-6294a90a13f52024-12-26WarningsExact identifier
application number: M020
Julep No Excuses Gel for Face SPF40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation298404c4-d4be-7395-e063-6294a90a86bf2024-12-26WarningsExact identifier
application number: M020
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUMHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, INC2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e2024-12-26WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation30b224f0-43f1-4c79-839e-3a970e4be3a52024-12-26WarningsExact identifier
application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREENHOMOSALATE, OCTISALATE, AND AVOBENZONECLINIQUE LABORATORIES LLCf4fe22b3-ccf2-4d67-8d20-5b5d3b69b4442024-12-25WarningsExact identifier
application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd1a3d76f-16dd-4533-8144-9a3175f6e15f2024-12-25WarningsExact identifier
application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15TITANIUM DIOXIDEESTEE LAUDER INCa04a9aaa-fa0f-4dde-a7a5-c4c561cc51b12024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEESTEE LAUDER INC0770e251-95d0-43de-88f1-bc0a29811e4e2024-12-25WarningsExact identifier
application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAKEUP ART COSMETICSc26ef380-1309-4a41-862f-eb319d38673d2024-12-25WarningsExact identifier
application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUMOCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICSff48435d-245a-4037-9afb-caee83c4c4152024-12-25WarningsExact identifier
application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.0fe63edf-7a49-4b33-88f1-f480f889d1942024-12-25WarningsExact identifier
application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.8e8c495e-d439-4735-a7cc-b44081b75b272024-12-25WarningsExact identifier
application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0fac5204-df18-4774-bb53-115513cb7ff02024-12-25WarningsExact identifier
application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC66e48ce0-9a5b-4250-b07b-1622b3814c3e2024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC2f93580c-c8e9-4822-91bf-a749cf4deb4e2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cab9-1b3e-e063-6394a90afe5d2024-12-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83403-101-018340301010160 mL in 1 TUBE60 mlHistorical
83403-101-02834030101021 TUBE in 1 BOX (83403-101-02) / 60 mL in 1 TUBE (83403-101-01) 1 tube2026-01-07NoNoCurrent