drug facts

drug facts
SPL v1
SPL
SPL Set ID 657d5090-30a8-46d0-879d-469178aa234d
Route
topical
Published
Effective Date 2018-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (5 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-01-25

Description

Titanium Dioxide 5.00% Zinc Oxide 5.00%


Medication Information

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
Other Information
  • Protect this product form excessive heat and direct sun
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.

Description

Titanium Dioxide 5.00% Zinc Oxide 5.00%

Principal Display Panel

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.
Active Ingredients

Titanium Dioxide 5.00%

Zinc Oxide 5.00%


Structured Label Content

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
Other Information
  • Protect this product form excessive heat and direct sun
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.

Principal Display Panel

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.
Active Ingredients

Titanium Dioxide 5.00%

Zinc Oxide 5.00%


Advanced Ingredient Data


Raw Label Data

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