Label: OP SPF45 FACE CLEAR ZINC POTION- octinoxate, zinc oxide, oxybenzone, octisalate, octocrylene 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, 2018

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  • SPL UNCLASSIFIED SECTION

    OP spf45 1oz Face Clear Zinc Potion

  • Active Ingredients

    Octinoxate 7.5%

  • Active Ingredients

    Zinc Oxide 7.0%

  • Active Ingredients

    Oxybenzone 5.0%

  • Active Ingredients

    Octisalate 5.0%

  • Active Ingredients

    Octocrylene 2.0%

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Re-apply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every two 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-sleeved shirts, pants, hats and sunglasses
      • Children under 6 months: ask a doctor.
  • Inactive Ingredients

    Acrylates Copolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzote, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Methylparaben, Propylene Glycol, Propylparaben, Sorbitan Stearate, Sorbityl Laurate, Stearyl Alcohol, Triethoxycaprylylsilane, Water, Xanthan Gum

  • Other Information

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

    Call toll free 1-800-715-3485

  • PRINCIPAL DISPLAY PANEL

    Clear Zinc Oxide
    Face Potion
    sunscreen
    Net WT. 1.0 OZ (28.5 g)

    PRINCIPAL DISPLAY PANEL Clear Zinc Oxide Face Potion sunscreen Net WT. 1.0 OZ (28.5 g)

  • INGREDIENTS AND APPEARANCE
    OP SPF45 FACE CLEAR ZINC POTION 
    octinoxate, zinc oxide, oxybenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBITYL LAURATE (UNII: 23XPH3M9LR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-203-0028.35 g in 1 CONTAINER; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2017
    Labeler - SolSkyn Personal Care LLC (080010329)
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