Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20: Package Insert and Label Information

YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20- titanium dioxide lotion
Mana Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

59735-170-01
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ZINC OXIDE
WATER
BUTYLENE GLYCOL
OCTYLDODECYL NEOPENTANOATE
PEG/PPG-18/18 DIMETHICONE
MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE
SODIUM CHLORIDE
ZINC CHLORIDE
LYSINE
TOCOPHEROL
TETRAHEXYLDECYL ASCORBATE
MAGNESIUM ASCORBYL PHOSPHATE
RETINOL
CAMELLIA OLEIFERA LEAF
CAMELLIA RETICULATA WHOLE
GINKGO BILOBA LEAF OIL
PANAX GINSENG LEAF
OCTYLDODECANOL
PHYTANTRIOL
GLYCERIN
TRIETHOXYCAPRYLYLSILANE
BORON NITRIDE
DEXTRIN PALMITATE (CORN; 20000 MW)
PALMITIC ACID
STEARIC ACID
ALUMINUM HYDROXIDE
HEXYLENE GLYCOL
DISODIUM EDTA-COPPER
POTASSIUM SORBATE
SODIUM DEHYDROACETATE
CAPRYLYL GLYCOL
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59735-170-01 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (59735-170-01)
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)

Revised: 01/2018 Mana Products

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