Label: BROAD SPECTRUM SPF 30 UP THE ANTI - titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Broad Spectrum SPF 30 Up The Anti
  • Active Ingredients

    Zinc Oxide 6.0%
    Titanium Dioxide 3.2%
    Close
  • Purpose

    Sunscreen

    Close
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
    Close
  • 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.
    Close
  • Keep out of reach of children.

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

    Close
  • Directions

    • apply to face and under throat after cleansing
    • reapply:
      • after excessive perspiration
    • 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 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
    Close
  • Inactive Ingredients

    water, ethylhexyl palmitate, cyclopentasiloxane, c12-15 alkyl benzoate, dimethicone, polysorbate 80, peg-100 stearate, glyceryl stearate, propylene glycol, polyglyceryl-6 isostearatem cetyl alcohol, sodium acrylate/sodium acryloyldimethyl laurate copolymer, glycerin, cyclohexasiloxane, caprylyl methicone, alumina, isohexadecane, boron nitride, triethoxysilylethyl polydimethylsiloxy hexyl dimethicone, sodium levulinate, lauryl  peg-9 polydimethylsiloxyethyl dimethicone, acrylates/ammonium methacrylate copolymer, phenoxyethanol, polyhydroxystearic acid, sodium anisate, triethoxycaprylylsilane, panthenol, iodopropynyl butylcarbamate, dmdm hydantoin, aloe barbadensis leaf juice, allantoin, disodium edta, methylparaben, ethylparaben, butylparaben, butylene glycol, propylparaben, isobutylparaben, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract, iron oxides.

    Close
  • Other Information

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

    Call toll free 1-866-424-6735 (weekdays)

    Close
  • SPL UNCLASSIFIED SECTION

    PRESCRIBEDsolutions is Distributed By Biopelle, Inc.

    A Ferndale Pharma Group Company, Ferndale, MI 48220

    Made In USA

    Close
  • Broad Spectrum SPF 30 Up The Anti 75ml (42485-005-01)
  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 30 UP THE ANTI  
    titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42485-005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 32 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42485-005-01 75 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/14/2012
    Labeler - Biopelle, Inc. (808158823)
    Establishment
    Name Address ID/FEI Business Operations
    Englewood Lab, LLC 172198223 manufacture(42485-005)
    Close