PROTEKT SPF-50 SHEER MINERAL SUNSCREEN- zinc oxide cream 
Protekt Products, Inc.

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PROTEKT SPF-50 Sheer Mineral Sunscreen

Drug Facts

Active Ingredients

Zinc Oxide 18.00%

Purpose

Sunscreen

Uses:

Warnings:

For external use only

Do not use

  • on damaged or broken skin.

When using this product

  • keep out of eyes. Rinse with water to remove 

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Other Information:

Inactive Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, *Carthamus Tinctorius (Safflower) Oil, Citric Acid, Decyl Glucoside, Dodecane, *Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. (*Certified Organic Ingredient)

Package Labeling:

Updated Label

PROTEKT SPF-50 SHEER MINERAL SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82912-322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION180 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DODECANE (UNII: 11A386X1QH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL LAURATE (UNII: Y98611C087)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
COCOA (UNII: D9108TZ9KG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CORN (UNII: 0N8672707O)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82912-322-0088 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/01/2022
Labeler - Protekt Products, Inc. (117541343)

Revised: 11/2023
Document Id: 09e35e72-c04e-4d9a-e063-6294a90acdd1
Set id: 6edc0941-bb21-4797-a875-81f727694774
Version: 3
Effective Time: 20231111
 
Protekt Products, Inc.