SUNSCREEN- zinc oxide sunscreen ointment 
Private Label Select Ltd CO

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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Suntegrity, Mineral Sun Stick, SPF 30 - Tinted Medium

Dosage and Administration

Warnings Section

Inactive Ingredients

Indications and Usage

Indications and Usage

Keep out of reach of children

Keep out of reach of children

OTC-Purpose Section

OTC-Purpose Section

OTC-Active Ingredient Section

OTC-Active ingredient section

Front Label

Front Label

Back Label

Back Label

SUNSCREEN 
zinc oxide sunscreen ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.BETA.-TOCOPHEROL (UNII: 9U6A490501)  
CASTOR OIL (UNII: D5340Y2I9G)  
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
COCOA BUTTER (UNII: 512OYT1CRR)  
WHITE WAX (UNII: 7G1J5DA97F)  
CANDELILLA WAX (UNII: WL0328HX19)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62932-218-2646 g in 1 TUBE; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2020
Labeler - Private Label Select Ltd CO (005415463)
Registrant - Private Label Select Ltd CO (005415463)

Revised: 7/2020
Document Id: aa837ee6-7b26-d4d0-e053-2a95a90a6885
Set id: aa837ee6-7b25-d4d0-e053-2a95a90a6885
Version: 1
Effective Time: 20200715
 
Private Label Select Ltd CO