Label: PERFECTLY POSH THROWING SHADE SPF30 BROAD SPECTRUM FACIAL SUNSCREEN- zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 11, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 6%

    Titanium Dioxide 4.6%

  • 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. Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

    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.
    • Children under 6 months of age: ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.

    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 10am-2pm.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Inactive Ingredients

    Water/Aqua, Organic Carthamus Tinctorius (Safflower) Oleosomes, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Diheptyl Succinate, Glycerin, Stearyl Alcohol, Methylcellulose, Phenylpropanol, Alumina, Stearic Acid, Cetyl Alcohol, Propanediol, Polyhydroxystearic Acid, Caprylyl Glycol, Gluconolactone, Lavandula Hybrida Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Triethoxycaprylylsilane, Sodium Benzoate, Sodium Phytate, Rhizobian Gum, Sodium Chloride, Sodium Hyaluronate, Phenoxyethanol, Tocopherol, Chlorphenesin, Citric Acid.

  • Other Information

    Protect this product from excessive heat and sun.

  • PRINCIPAL DISPLAY PANEL

    Broad Spectrum

    Facial Sunscreen

    SPF 30

    1.6 oz/45 g

    Label

  • INGREDIENTS AND APPEARANCE
    PERFECTLY POSH THROWING SHADE SPF30 BROAD SPECTRUM FACIAL SUNSCREEN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71140-0212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEARIC ACID D7 (UNII: T3B081197X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71140-0212-745 g in 1 TUBE; Type 0: Not a Combination Product11/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2016
    Labeler - Perfectly Posh, LLC (063537897)