BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]

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  • BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]

BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0092-4
Set ID 3b759dcf-714a-4228-9ffa-183ec3e640c3
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Octinoxate 7.5 %, Octisalate 5 %, Oxybenzone 2 %, Titanium Dioxide 2.8 %, and Zinc Oxide  4 %

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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. Apply a test patch on a small area on the skin before use.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin of cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun especially from 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Disodium EDTA, Glycerin, Isopropyl Palmitate, Methylparaben, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Polyethylene, Polyquaternium-37, PPG-1 Trideceth-6, Propylene Glycol Dicaprylate/Dicaprate, Propylparaben, Tocopheryl Acetate, Water

  • Other information

    • protect this product from excesive heat and direct sun
  • Questions or Comments?

    The Children's Healthcare Research

    Group, PO Box 830, Westport, MA 02790

  • PRINCIPAL DISPLAY PANEL - 180 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label


    Baby

    blanket

    Sunscreen Lotion

    for Babies

    Titanium Dioxide Formula

    BROAD

    SPECTRUM

    SPF 50+

    WATER RESISTANT

    (80 MINUTES)

    Paba-free

    Hypoallergenic

    Pediatrician &

    Dermatologist Tested

    6.0 FL OZ (180 mL)

  • INGREDIENTS AND APPEARANCE
    BABY BLANKET  BROAD SPECTRUM SPF 50
    octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE77.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20.6 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30.9 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION41.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0092-4180 mL in 1 BOTTLE; Type 0: Not a Combination Product12/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/23/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0092) , pack(58443-0092) , manufacture(58443-0092) , analysis(58443-0092)
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