Label: GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.1- titanium dioxide 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 November 17, 2011

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

  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 9.694 %, Octinoxate 5.00 %, Zinc Oxide 2.94%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Glycerin, Dicaprylyl Carbonate, Dimethicone, Caprylyl Methicone, Iron Oxides (CI 77492), Magnesium Sulfate, Mica (CI 77019), Disteardimonium Hectorite, Sorbitan Sesquioleate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Euterpe Oleracea Fruit Extract, Ozokerite, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Iron Oxides (CI 77491), Stearic Acid, Methylparaben, Beeswax, Chlorphenesin, Triethoxycaprylylsilane, Fragrance(Parfum), Iron Oxides (CI 77499), Propylparaben, Disodium EDTA, Adenosine, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Melissa Officinalis Leaf Extract, Aspalathus Linearis Extract, Thymus Vulgaris (Thyme) Extract, Jasminum Officinale (Jasmine) Extract, Rosmarinus Officinalis (Rosemary) Extract, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Hydroxyethyl Ethylcellulose

  • PURPOSE

    Purpose: UVA/UVB protection

  • WARNINGS

    Warnings:
    For external use only.
    Avoid contact with eyes. Do not swallow.
    Discontinue use if signs of irritation appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage:
    After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    GOOD AFTERNOON BERRY BERRY TEA BB  SPF35 PA PLUS PLUS NO.1
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-044
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.90 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.50 g  in 30 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.88 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ACAI (UNII: 46AM2VJ0AW)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ADENOSINE (UNII: K72T3FS567)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    BEACH STRAWBERRY (UNII: 98542F2TQS)  
    RASPBERRY (UNII: 4N14V5R27W)  
    BLACKBERRY (UNII: 8A6OMU3I8L)  
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    THYME (UNII: CW657OBU4N)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    ROSEMARY (UNII: IJ67X351P9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-044-0130 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture