YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20 lotion

Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Mana Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 5.00%

Zinc Oxide 5.00%

Use

• 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.

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 docor if rash occurs
• Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use water resistant sunscreen if swimming or sweathing
• Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor

Inactive Ingredients

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginko Biloba Leaf Extract, Panax Ginsing Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Mechiecone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol. May Contain (+/-): Mica, Iron Oxides.

Other Information

• Protect this product form excessive heat and direct sun

Principal Display Panel

INGREDIENTS AND APPEARANCE

YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20 
your name cosmetics mineral sheet tint broad spectrum spf 20 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ZINC OXIDE (UNII: SOI2LOH54Z)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
RETINOL (UNII: G2SH0XKK91)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CAMELLIA RETICULATA WHOLE (UNII: BS1R5R0GX4)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
PANAX GINSENG LEAF (UNII: F055A23N6X)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHYTANTRIOL (UNII: 8LVI07A72W)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BORON NITRIDE (UNII: 2U4T60A6YD)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-170-01	1 in 1 CARTON	01/25/2018
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/25/2018

Labeler - Mana Products (078870292)