Label: PROTEKT SPF-50 SHEER MINERAL SUNSCREEN- zinc oxide cream
- NDC Code(s): 82912-322-00
- Packager: Protekt Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
-
Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- 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:
-
INGREDIENTS AND APPEARANCE
PROTEKT SPF-50 SHEER MINERAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82912-322 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 180 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82912-322-00 88 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/01/2022 Labeler - Protekt Products, Inc. (117541343)