SENSIBLE SPF 32 MINERAL SUNSCREEN- zinc oxide cream

Sensible SPF 32 Mineral Sunscreen by

Drug Labeling and Warnings

Sensible SPF 32 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredients

Zinc Oxide USP** 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

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 occurs

Keep out of reach of children, if product is swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only if used as directed with other sun protection measures

Directions

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply:

after swimming or sweating
immediately after towel drying
at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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.

Children under 6 months. Ask a doctor.

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply:
• after swimming or sweating
• immediately after towel drying
• at least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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.
• Children under 6 months. Ask a doctor
  

Inactive Ingredients

Artesian Spring Water, Extra Virgin Olive Oil*, Vegetable Gycerin*, Jojoba Oil*, Shea Butter*, Vegetable Emulsifying Wax NF# (polysorbate 60 and cetearyl alcohol), Vitamin E.

*Certified Organic by USDA/NOP **non-nano, uncoated, French Process zinc oxide

Other Information

protect this product from excessive heat and direct sun

INGREDIENTS AND APPEARANCE

SENSIBLE SPF 32 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-1501
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
SHEA BUTTER (UNII: K49155WL9Y)	1.93 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	1.38 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	26.95 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	1.125 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.125 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	3.75 g  in 100 g
JOJOBA OIL (UNII: 724GKU717M)	3.75 g  in 100 g
WATER (UNII: 059QF0KO0R)	35 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-1501-1	85 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2022

Labeler - Kabana Skin Care (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(73369-1501)