Label: CELEBEAU STAR SECRET CUSHION 01 PINK STAR- octinoxate, octisalate, zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 28, 2018

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

  • ACTIVE INGREDIENT

    Titanium Dioxide 8.300%

    Octinoxate 7.000%

    Octisalate 3.000%

  • 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

    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, Caprylyl Methicone, Cyclohexasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate, Sodium Chloride, Dimethicone, Trimethylsiloxysilicate, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Isoamyl Laurate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Beeswax, Disteardimonium Hectorite, Polypropylsilsesquioxane, Mica (CI 77019), Dimethicone/Vinyl Dimethicone Crosspolymer, Isododecane, Alumina, Iron Oxides (CI 77491), Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Chlorphenesin, Trihydroxystearin, Dipropylene Glycol, 1,2-Hexanediol, Hydroxyacetophenone, Squalane, Tocopheryl Acetate, Propylene Carbonate, Iron Oxides (CI 77499), Fragrance(Parfum), Adenosine, Triethoxycaprylylsilane, Disodium EDTA, Silica, Tin Oxide (CI 77861), Sophora Angustifolia Root Extract, Citrus Junos Fruit Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi (Grapefruit) Seed Extract, Eugenia Caryophyllus (Clove) Flower Extract, Rosa Damascena Flower Water, Diamond powder, Prunus Persica (Peach) Fruit Extract, Sodium Hyaluronate, Cocos Nucifera (Coconut) Fruit Extract, Tocopherol, Hydrolyzed Collagen

  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CELEBEAU STAR SECRET CUSHION 01 PINK STAR 
    octinoxate, octisalate, zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70142-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 15 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.45 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AMILOXATE (UNII: 376KTP06K8)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    Niacinamide (UNII: 25X51I8RD4)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ALCOHOL (UNII: 3K9958V90M)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    Isododecane (UNII: A8289P68Y2)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70142-003-021 in 1 CARTON03/28/2018
    1NDC:70142-003-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/28/2018
    Labeler - SD BIOTECHNOLOGIES CO., LTD (688278067)
    Registrant - SD BIOTECHNOLOGIES CO., LTD (688278067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cit Co., Ltd.690081646manufacture(70142-003)