SUNSCREEN- zinc oxide sunscreen stick 
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.

----------

Suntegrity, Mineral Sun Stick, SPF 30 - Tinted Light

ACTIVE INGREDIENTS

ACTIVE INGREDIENTS

DOSAGE AND ADMIN.

Dosage and Administration

INACTIVE INGREDIENT

Inactive Ingredients

OTC- KEEP OUT OF REACH

OTC KEEP OUT OF REACH

OTC-PURPOSE

PUPOSE

INDICATIONS AND USAGE

Indications and Usage

WARNINGS SECTION

WARNINGS

BACK LABEL

Back Label

FRONT LABEL

FRONT LABEL

SUNSCREEN 
zinc oxide sunscreen stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-219
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
COCOA BUTTER (UNII: 512OYT1CRR)  
CASTOR OIL (UNII: D5340Y2I9G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WHITE WAX (UNII: 7G1J5DA97F)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SHEA BUTTER (UNII: K49155WL9Y)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
.BETA.-TOCOPHEROL (UNII: 9U6A490501)  
Product Characteristics
Colorbrown (Light Brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62932-219-2646 g in 1 CONTAINER; 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)

Revised: 7/2020
Document Id: aa97bab0-5886-3e6c-e053-2a95a90a4330
Set id: aa97bab0-5885-3e6c-e053-2a95a90a4330
Version: 1
Effective Time: 20200716
 
Private Label Select Ltd CO