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PCA SKIN Body Hydrator (Physicians Care Alliance, LLC DBA PCA SKIN)

Available Formats

Dosage Form Package Information Links
LOTION 198.4 g in 1 BOTTLE (68726-167-01) Label Information
LOTION 1 TUBE in 1 CARTON (68726-167-04) > 9 g in 1 TUBE (68726-167-03) Label Information
LOTION 48 g in 1 BOTTLE (68726-167-02) Label Information

Complete PCA SKIN Body Hydrator Information

  • ACTIVE INGREDIENT

    DRUG FACTS

    _________________________________

    Active Ingredient:         Purpose:

    Zinc Oxide(9.8%)         Sunscreen (UVA UVB)

    Octinoxate(7.5%)         Sunscreen (UVB)


  • INDICATIONS & USAGE

    Uses:  Provides high protection against sunburn.


  • WARNINGS

    Warnings: For external use only. Keep out of eyes. Rinse with water to remove.  Stop use and consult a physician ifskin rash and irritation develops and lasts.


  • DOSAGE & ADMINISTRATION

    Directions:For use by adults and children six months and older.  apply liberally to exposed areas at least 30 minutes prior to sun exposure.  Reapply every two hours or as needed after swimming or perspiring.  Consult a physician prior to use on children under six months of age.

    Other Information:  Sun Alert. Limiting sun exposure, wearing protecting clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.


  • INACTIVE INGREDIENT

    Inactive Ingredients:Water/Aqua/Eau, Ethylhexyl Palmitate, GLycerin, Cyclopentasiloxane, Isononyl Isononanoate, Cetearyl Alcohol, SD Alcohol 40-B, Polyacrylate-13, Dimethicone, Tocopheryl Acetate, Triethoxycaprylylsilane, Lactic Acid, Kojic Acid, Butylene Glycol, Morus Alba Root Extract, Arctostaphylos, Uva Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Caffeine, Silybum Marianum Extract, Arginine, Microcrystalline Cellulose, C20-22 Allcohols, Polyisobutene, Cetearyl Glucoside, Caprylyl Glycol, Cellulose Gum, Aloe Barbadensis Leaf Juice, Sodium PCA, Sodium Hyaluronate, Magnesium Ascorbyl Phosphate, Tetrasodium EDTA, Cirtus Grandis (Grapefruit) Peel oil, Ethylhexylglycerin, Phenoxyethanol.


  • INGREDIENTS AND APPEARANCE
    PCA SKIN BODY HYDRATOR  SPF30
    zinc oxide and octinoxate lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68726-167
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.8 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CAFFEINE (UNII: 3G6A5W338E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MORUS ALBA ROOT BARK (UNII: SV6B76DK9N)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ARGININE (UNII: 94ZLA3W45F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    ALCOHOL (UNII: 3K9958V90M)  
    MILK THISTLE (UNII: U946SH95EE)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68726-167-05 1 in 1 CARTON 10/01/2010
    1 NDC:68726-167-01 198.4 g in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:68726-167-02 48 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2010
    3 NDC:68726-167-04 1 in 1 CARTON 10/01/2010
    3 NDC:68726-167-03 9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/01/2010
    Labeler - Physicians Care Alliance, LLC DBA PCA SKIN (969945133)