Label: ALPHA-H TOTAL ECLIPSE- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 25, 2023

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  • Alpha-H Total Eclipse

    PDP

  • INGREDIENTS AND APPEARANCE
    ALPHA-H TOTAL ECLIPSE 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55528-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.7 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-7 (UNII: 0841698D2F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SQUALANE (UNII: GW89575KF9)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    CETETH-20 (UNII: I835H2IHHX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55528-400-021 in 1 CARTON05/05/2023
    1NDC:55528-400-0140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/05/2023
    Labeler - Alpha-H (754473957)
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