DRUG FACTS

ACTIVE INGREDIENTS

Zinc Oxide (non-nano) 12.5%

Titanium Dioxide (non-nano) 4.5%

Purpose

Sunscreen

USES

Helps prevent sunburn
If used as directed with othe sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Shake well before use • Apply liberally to all exposed skin 15 minutes before sun exposure • - after 80 minutes of swimming or sweating • Immediately after towel drying - At least every 2 hours • Sun Protection Measures: Spending time in the sun increaases 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 measres including: • Limit time in the sun, especially between 10am and 2pm • Wear long-sleeved shorts, pants, hats and sunglasses • For children under 6 months of age - ask a doctor. Reapply

OTHER INFORMATION

Store below 90ºF / 30ºC

INACTIVE INGREDIENTS

Aqua, Glycine Max (Soybean) Oil, Hydroxy Ethyl Cellulose (Cellulose Gum), Xanthan Gum, Glycerol Mono Stearate, Barium Sulphate, Cetearyl Alcohol, Glycerin, Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Copernicia Cerifera (Carnauba) Wax, Sodium Benzoate, Potassium Sorbate, Potassium Cetyl Phosphate, Cucumber Potpourri, Citrullus Vulgaris (Kalahari Melon) Oil, Simmondsia Chenensis (Jojoba) Oil, Argania Spinosa (Argan) Oil, Aloe Vera Extract, Ascorbic Acid (Vitamin C), Tocopherol Acetate (Vitamin E).

Package Labeling:

Label

SETT MINERAL SUNSCREEN SPF 50
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83478-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	125 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
XANTHAN GUM (UNII: TTV12P4NEE)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
JOJOBA OIL (UNII: 724GKU717M)
ARGAN OIL (UNII: 4V59G5UW9X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83478-000-00	100 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/01/2023

Labeler - Sett Surf, Ltd. (225883876)

SETT Mineral Sunscreen SPF 50