LAUNDRYOU MOISTURE SUN CUSHION CLEAR- titanium dioxide, zinc oxide cream 
bvmt Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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83024-001_LAUNDRYOU MOISTURE SUN CUSHION CLEAR

Titanium Dioxide 10.03%

Zinc Oxide 4.90%

Sunscreen

Helps prevent sunburn

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

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

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

image description

LAUNDRYOU MOISTURE SUN CUSHION CLEAR 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83024-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.03 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83024-001-021 in 1 CARTON10/05/2022
1NDC:83024-001-0125 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/05/2022
Labeler - bvmt Co.,Ltd. (695523184)
Registrant - bvmt Co.,Ltd. (695523184)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(83024-001)

Revised: 10/2022
Document Id: ea51dee7-025f-3fc1-e053-2995a90a3580
Set id: dd956b14-36f6-4b8a-a654-a00538a3a9e6
Version: 3
Effective Time: 20221005
 
bvmt Co.,Ltd.