BETA-GLUCAN MILD SUNSCREEN- titanium dioxide, zinc oxide lotion

BETA-GLUCAN MILD SUNSCREEN by

Drug Labeling and Warnings

BETA-GLUCAN MILD SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by IUNIK Co., Ltd, UCL Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titamiun Dioxide 5.61%

Zinc Oxide 10.08%

PURPOSE

Sunscreen

USES

- Helps prevent sunburn.

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

• For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

- If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.
• Sun protection measures.

- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 a.m.–2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS

Water, Dimethicone, Butyloctyl Salicylate, Neopentyl Glycol Diheptanoate, Glycerin, Trisiloxane, Silica, Isotridecyl Isononanoate, Trimethylsiloxysilicate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Trimethicone, Isostearyl Polyglyceryl-3 Dimethicone, Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Magnesium Sulfate, 1,2-Hexanediol, Benzotriazolyl Dodecyl p-Cresol, Triethoxycaprylylsilane, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Caprylyl Glycol, Hydroxypropyl Bispalmitamide MEA, Butylene Glycol, Pinus Densiflora Leaf Extract, Hydrogenated Lecithin, Bacillus Ferment, Cetearyl Alcohol, Beta-Glucan, Scutellaria Baicalensis Root Extract, Tremella Fuciformis Polysaccharide, Centella Asiatica Extract, Ceramide NP, Ceramide NG, Cholesterol, Phytosphingosine, Papaver Rhoeas Flower Extract, Ceramide AS, Ceramide AP, Ceramide EOP

BETA-GLUCAN MILD SUNSCREEN

BETA-GLUCAN MILD SUNSCREEN

INGREDIENTS AND APPEARANCE

BETA-GLUCAN MILD SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83403-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.08 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.61 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
BACILLUS POLYFERMENTICUS (UNII: 6UQO3086C7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)
PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
CERAMIDE NG (UNII: C04977SRJ5)
PAPAVER RHOEAS FLOWER (UNII: Y1MLS7E68X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRISILOXANE (UNII: 9G1ZW13R0G)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICA (UNII: ETJ7Z6XBU4)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ODETIGLUCAN (UNII: Q6X9CNN54X)
CERAMIDE AP (UNII: F1X8L2B00J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM SULFATE (UNII: DE08037SAB)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROXYPROPYL BISPALMITAMIDE MEA (UNII: EVX7NC9YVE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CERAMIDE 4 (UNII: SF3LP91341)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CERAMIDE NP (UNII: 4370DF050B)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83403-101-02	1 in 1 BOX	01/07/2026
1	NDC: 83403-101-01	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/07/2026

Labeler - IUNIK Co., Ltd (695653625)

Establishment
Name	Address	ID/FEI	Business Operations
UCL Co., Ltd.		696364043	manufacture(83403-101)