Label: SNP ANIMAL TIGER LONG-LASTING COVER CUSHION- titanium dioxide, octinoxate, octisalate 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 October 16, 2016

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

  • ACTIVE INGREDIENT

    Titanium Dioxide 12.16%
    Octinoxate 7.00%
    Octisalate 3.00%

  • 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, Butylene Glycol, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, SD Alcohol 40-B, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isoamyl Laurate, Dicaprylyl Carbonate, Sodium Chloride, Iron Oxides (CI 77492), Trimethylsiloxysilicate, Sorbitan Sesquioleate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Beeswax, Disteardimonium Hectorite, Polypropylsilsesquioxane, Potassium Sorbate, Dimethicone, Iron Oxides (CI 77491), Trihydroxystearin, Synthetic Fluorphlogopite, Caprylyl Glycol, Alumina, Squalane, Hamamelis Virginiana (Witch Hazel) Water, Tocopheryl Acetate, Propylene Carbonate, Fragrance(Parfum), Cellulose, Iron Oxides (CI 77499), 1,2-Hexanediol, Propanediol, Talc, Ultramarines (CI 77007), Adenosine, Trimethoxycaprylylsilane, Disodium EDTA, Illicium Verum (Anise) Fruit Extract, Tin Oxide (CI 77861), Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Algae Extract, Hizikia Fusiforme Extract, Codium Fragile Extract, Tocopherol, Rosa Damascena Flower Water, Camellia Japonica Flower Extract, Butyl Avocadate, Hydrolyzed Hyaluronic Acid, Glycine, Bambusa Vulgaris Leaf/Stem Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Chrysanthemum Morifolium Flower Extract, Prunus Mume Flower Extract, Lilium Tigrinum Extract, Prunus Serrulata Flower Extract, Sambucus Nigra Flower Extract, Nelumbo Nucifera Flower Extract, Rosa Multiflora Fruit Extract, Mirabilis Jalapa Extract, Glutamic Acid, Lysine, Leucine, Methionine, Valine, Serine, Cysteine, Aspartic Acid, Alanine, Arginine, Isoleucine, Tyrosine, Threonine, Phenylalanine, Proline, Histidine, Phenoxyethanol, Milk Protein Extract

  • OTHER SAFETY INFORMATION

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

  • QUESTIONS

    Call 1-844-767-6275 or Email sdbio.usa@sdbiotech.co.kr

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SNP ANIMAL TIGER LONG-LASTING COVER CUSHION 
    titanium dioxide, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70142-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.4592 g  in 12 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.84 g  in 12 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.36 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    AMILOXATE (UNII: 376KTP06K8)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ALCOHOL (UNII: 3K9958V90M)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SQUALANE (UNII: GW89575KF9)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TALC (UNII: 7SEV7J4R1U)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    ADENOSINE (UNII: K72T3FS567)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STAR ANISE FRUIT (UNII: CK15HA8438)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    SARGASSUM FUSIFORME (UNII: X436TJ4A11)  
    CODIUM FRAGILE (UNII: MSE6FUU012)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
    GLYCINE (UNII: TE7660XO1C)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
    PRUNUS MUME FLOWER (UNII: 2N8872050J)  
    LILIUM LANCIFOLIUM BULB (UNII: 47Z05W73EZ)  
    PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)  
    MIRABILIS JALAPA SEED (UNII: QM99K42TFS)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    LYSINE (UNII: K3Z4F929H6)  
    LEUCINE (UNII: GMW67QNF9C)  
    METHIONINE (UNII: AE28F7PNPL)  
    VALINE (UNII: HG18B9YRS7)  
    SERINE (UNII: 452VLY9402)  
    CYSTEINE (UNII: K848JZ4886)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    ALANINE (UNII: OF5P57N2ZX)  
    ARGININE (UNII: 94ZLA3W45F)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    TYROSINE (UNII: 42HK56048U)  
    THREONINE (UNII: 2ZD004190S)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    HISTIDINE (UNII: 4QD397987E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CASEIN (UNII: 48268V50D5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70142-002-021 in 1 CARTON10/16/2016
    1NDC:70142-002-0112 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 finalpart35210/16/2016
    Labeler - SD BIOTECHNOLOGIES CO., LTD (688278067)
    Registrant - SD BIOTECHNOLOGIES CO., LTD (688278067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cit Co., Ltd690081646manufacture(70142-002)