SVENS EVERYDAY MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion 
Svens, Inc

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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Svens Everyday Mineral Sunscreen

Svens Everyday Mineral Sunscreen

Svens Sunscreen label

SVENS EVERYDAY MINERAL SUNSCREEN 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72743-4314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
STEARETH-20 (UNII: L0Q8IK9E08)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
ALLANTOIN (UNII: 344S277G0Z)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
POLYESTER-7 (UNII: 0841698D2F)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
Product Characteristics
Colorwhite (Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72743-4314-1100 mL in 1 TUBE; Type 0: Not a Combination Product04/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/03/2019
Labeler - Svens, Inc (018940784)

Revised: 4/2019
Document Id: 9121b44e-437e-6787-e053-2a95a90a8292
Set id: 912170ae-124c-5eb9-e053-2995a90a0ba3
Version: 1
Effective Time: 20190403
 
Svens, Inc