IN YOUR FACE MINERAL TINT SPF 31- zinc oxide cream

In Your Face Mineral Tint SPF 31 by

Drug Labeling and Warnings

In Your Face Mineral Tint SPF 31 by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 25%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• 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

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours

Directions

• Children under 6 months. Ask a doctor.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 AM - 2 PM.
• Wear long-sleeved shirts, pants, hats and sunglasses

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove.

Inactive Ingredients

Artesian Spring Water, Extra Virgin Olive Oil*, Jojoba Oil*, Vegetable Glycerin*, Shea Butter*, Vgetable Emulsifying Wax NF+, Vitamin E, Iron Oxides. *Organic

Other Information

• Protect this product from excessive heat and direct sun

INGREDIENTS AND APPEARANCE

IN YOUR FACE MINERAL TINT SPF 31 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-1601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	35 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.15 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	25.95 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.125 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	3.75 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	1.93 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	0.85 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	1.125 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	1.38 g  in 100 g
JOJOBA OIL (UNII: 724GKU717M)	3.75 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-1601-1	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	07/14/2023

Labeler - Kabana Skin Care (080237112)

Registrant - Kabana Skin Care (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(73369-1601)