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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Broad Spectrum SPF 30 Up The Anti


  • Active Ingredients

    Zinc Oxide 6.0% Titanium Dioxide 3.2%

  • Purpose

    Sunscreen

  • 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.
  • 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 to face and under throat after cleansing
    • reapply:
      • after excessive perspiration
    • 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: Sun Protection Measures.
      • 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, 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.

  • Other Information

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

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

  • SPL UNCLASSIFIED SECTION

    PRESCRIBEDsolutions is Distributed By Biopelle, Inc.

    A Ferndale Pharma Group Company, Ferndale, MI 48220

    Made In USA

  • Broad Spectrum SPF 30 Up The Anti 75ml (42485-005-01)


    UPTHEANTI

    UPTHEANTIBase

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 30 UP THE ANTI 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) 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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42485-005-0175 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/14/2012
    Labeler - Biopelle, Inc. (808158823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.172198223manufacture(42485-005)
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