Label: LAUNDRYOU CLEAR DEFENSE CUSHION GLOW 21 UYUNI BEIGE- octinoxate, titanium dioxide, homosalate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 5, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Titanium Dioxide 10.03%
    Octinoxate 7.00%

    Zinc Oxide 4.90%

    Octisalate 4.50%

  • PURPOSE

    Sunscreen

  • 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

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, Phenyl Trimethicone, Trimethylsiloxysilicate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Dipropylene Glycol, Niacinamide, Triethyl Citrate, Triethylhexanoin, VP/Hexadecene Copolymer, 1,2-Hexanediol, Mica (CI 77019), Disteardimonium Hectorite, Magnesium Sulfate, Kaolin, Iron Oxides (CI 77492), Aluminum Hydroxide, Polyhydroxystearic Acid, Chlorella Vulgaris Extract, Glucose, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Stearic Acid, Iron Oxides (CI 77491), Fructooligosaccharides, Fructose, Triethoxycaprylylsilane, Fragrance(Parfum), Adenosine, Trisodium Ethylenediamine Disuccinate, Iron Oxides (CI 77499), Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Artemisia Annua Leaf Extract, Ophiopogon Japonicus Root Extract, Ethylhexylglycerin, Panthenol, Totarol, Tocopherol, Glycerin, Sea Water, Potassium Benzoate, Litchi Chinensis Pericarp Extract

  • OTHER SAFETY INFORMATION

    Protect the product in the container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LAUNDRYOU CLEAR DEFENSE CUSHION GLOW 21 UYUNI BEIGE 
    octinoxate, titanium dioxide, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83024-002
    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
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 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)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MICA (UNII: V8A1AW0880)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    KAOLIN (UNII: 24H4NWX5CO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ADENOSINE (UNII: K72T3FS567)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    OREGANO (UNII: 0E5AT8T16U)  
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
    ARTEMISIA ANNUA LEAF (UNII: E4M09UY5BL)  
    OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TOTAROL (UNII: 67NH2854WW)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    LITCHI FRUIT (UNII: Y5P61KP51E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83024-002-021 in 1 CARTON10/05/2022
    1NDC:83024-002-0113 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(83024-002)