PACIFICA CC BROAD SPECTRUM SPF 17 LIGHT (ZINC OXIDE) CREAM [PACIFICA INC.]

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PACIFICA CC BROAD SPECTRUM SPF 17 LIGHT (ZINC OXIDE) CREAM [PACIFICA INC.]
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Set ID ad5b39df-f7a4-4574-b946-96965d91bdfe
Category HUMAN OTC DRUG LABEL
Packager Pacifica Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts


  • Active ingredient

    ZInc Oxide 11.4%

  • 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

    STOP USE AND ASK A DOCTOR

    IF RASH OCCURS

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure
    Use a water resistant sunscreen if swimming or sweating
    Reapply at least every 2 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 value 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:

    water (aqua), caprylic/capric triglyceride, sorbitan sesquioleate, dimethicone, potassium cetyl phosphate, glycerin, silica, jojoba esters, ceteraryl olivate, sorbitan olivate, mica, citric acid, potassium sorbate, sodium dehydroacetate, sodium benzoate, fragrance, sodium hyaluronate, cocos nucifera (coconut) water, withania somnifera root extract, carthamus tinctorius (safflower) seed oil, macrocystis pyrifera extract, linalool, amyl cinnamal, titanium Dioxide, CI 77891, Iron oxides CI 77491, CI 77492, and CI77499

  • Other information:

    • Protect this product from excessive heat and direct sun
  • Questions or comments?

    Call toll free 1-888-322-2466 (8am to 5pm Pacific time, Monday-Friday)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PACIFICA CC BROAD SPECTRUM SPF 17 LIGHT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE114 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYL JOJOBATE (UNII: 2351QH8W1N)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    MICA (UNII: V8A1AW0880)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    COCONUT JUICE (UNII: AMN6S4M09G)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61197-000-001 in 1 BOX11/21/2013
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/21/2013
    Labeler - Pacifica Inc. (868275517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Columbia Cosmetics Manufacturing, Inc.068267863manufacture(61197-000)
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