PROTEKT SPF-50 SHEER MINERAL SUNSCREEN- zinc oxide cream

PROTEKT SPF-50 Sheer Mineral Sunscreen by

Drug Labeling and Warnings

PROTEKT SPF-50 Sheer Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Protekt Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 18.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• higher SPF gives more sunburn protection
• retains SPF after 80 minutes of swimming or sweating
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

• 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:

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, *Carthamus Tinctorius (Safflower) Oil, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Glycerin, Dodecane, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Isododecane, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol, Tridecyl Salicylate, Trimethylsiloxysilicate, Xanthan Gum

(*Certified Organic Ingredient)

Package Labeling:

INGREDIENTS AND APPEARANCE

PROTEKT SPF-50 SHEER MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82912-323
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER (UNII: 4VBL71TY4Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
DODECANE (UNII: 11A386X1QH)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
ISODODECANE (UNII: A8289P68Y2)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82912-323-00	170 g in 1 BOTTLE; 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)