ERINS FACES MINERAL SPF 32 SUNSCREEN- zinc oxide sunscreen cream

Erins Faces Mineral SPF 32 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Questions?

Call 1.917.701.0644

DRUG FACTS

Active Ingredients

Zinc Oxide USP** 25%

Use

helps prevent sunburn

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 doctorif rash occurs

Directions

Apply liberally 15 minutes before sun exposure

Reapply 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.

Use a water resistant sunscreen if swimming or sweating

Children under 6 months. Ask a doctor

Inactive Ingredients

Aqua (Eldorado Springs Artesian water), Olea Europaea (Olive) Fruit Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, vegetable Glycerine, Butyrospermum Parkii (Shea) Butter*, Vegetable Emulsifying Wax NF, Tocopherol (Vitamin E).

*Organic Ingredients

Other Information

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

INGREDIENTS AND APPEARANCE

ERINS FACES MINERAL SPF 32 SUNSCREEN 
zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-1401
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
JOJOBA OIL (UNII: 724GKU717M)	3.75 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.125 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	1.125 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	1.38 g  in 100 g
WATER (UNII: 059QF0KO0R)	35 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	3.75 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	1.93 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	26.95 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-1401-1	1 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2021

Labeler - Kabana Skin Care (080237112)

Registrant - Kabana Skin Care (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(73369-1401)