LAUNDRYOU MOISTURE SUN CUSHION CLEAR- titanium dioxide, zinc oxide cream

LAUNDRYOU MOISTURE SUN CUSHION CLEAR by

Drug Labeling and Warnings

LAUNDRYOU MOISTURE SUN CUSHION CLEAR by is a Otc medication manufactured, distributed, or labeled by bvmt Co.,Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 10.03%

Zinc Oxide 4.90%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

WARNINGS

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Water, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Propylheptyl Caprylate, Trimethylsiloxysilicate, Acrylates Copolymer, Alcohol, Lauryl Polyglyceryl-3, Polydimethylsiloxyethyl Dimethicone, C12-15 Alkyl Benzoate, C18-21 Alkane, Methyl Trimethicone, Polyglyceryl-2 Dipolyhydroxystearate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Isododecane, Magnesium Sulfate, 1,2-Hexanediol, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Hydroxyacetophenone, Trisodium Ethylenediamine Disuccinate, Polyglycerin-6, Origanum Vulgare Leaf Extract, Tocopherol, Chamaecyparis Obtusa Leaf Extract, Glycerin, Sea Water, Potassium Benzoate, Ascorbyl Palmitate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LAUNDRYOU MOISTURE SUN CUSHION CLEAR 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83024-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.03 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C18-C21 ALKANE (UNII: 33822S0M40)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
POLYGLYCERIN-6 (UNII: M51422LRAM)
OREGANO (UNII: 0E5AT8T16U)
TOCOPHEROL (UNII: R0ZB2556P8)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83024-001-02	1 in 1 CARTON	10/05/2022
1	NDC: 83024-001-01	25 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/05/2022

Labeler - bvmt Co.,Ltd. (695523184)

Registrant - bvmt Co.,Ltd. (695523184)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(83024-001)