ALPHA-H TOTAL ECLIPSE- titanium dioxide, zinc oxide lotion 
Alpha-H

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.

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Alpha-H Total Eclipse

Alpha-H Total Eclipse

PDP

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)

Revised: 5/2023
Document Id: fc8a2605-d815-5cf8-e053-6394a90ab9d2
Set id: fc8a4efe-7d5e-5f44-e053-6394a90a80aa
Version: 1
Effective Time: 20230525
 
Alpha-H