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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 15, 2017

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

  • 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), Carthamus Tinctorius (Safflower) Oleosomes, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Diheptyl Succinate, Glycerin, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Methylcellulose, Phenylpropanol, Alumina, Stearic Acid, 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

    Tube

  • 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:71140-0332
    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
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEARIC ACID D7 (UNII: T3B081197X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    RHIZOBIAN GUM (UNII: 0XNZ14VU7K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71140-0332-345 g in 1 TUBE; Type 0: Not a Combination Product02/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/15/2017
    Labeler - Perfectly Posh, LLC (063537897)