drug facts

drug facts
SPL v1
SPL
SPL Set ID ae6a86d2-a95b-4fa8-9676-233ef9fdc3b0
Route
topical
Published
Effective Date 2017-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 g) titanium dioxide (5 g) zinc oxide (0.99 g)
Inactive Ingredients
water dimethicone glycerin peg/ppg-18/18 dimethicone butylene glycol trimethylsiloxysilicate (m/q 0.6-0.8) saccharide isomerate tocopherol ascorbyl palmitate caprylic/capric/lauric triglyceride octyldodecyl neopentanoate ethylhexyl palmitate nylon-12 boron nitride dextrin palmitate (corn; 20000 mw) sodium chloride aluminum hydride polymethylsilsesquioxane (11 microns) dimethylmethoxy chromanyl palmitate phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate calcium silicate palmitic acid stearic acid citric acid monohydrate lecithin, soybean sodium citrate triethyl citrate disteardimonium hectorite xanthan gum alcohol methicone (20 cst) triethoxycaprylylsilane lysine potassium chloride magnesium chloride zinc chloride sodium dehydroacetate magnesium ascorbyl phosphate octyldodecanol potassium sorbate disodium edta-copper caprylyl glycol hexylene glycol phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-02-21

Description

Octinoxate 7.5% Titanium Dioxide 5.00% Zinc Oxide 0.99%


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

Aqua/Water/Eau, Dimethicone, Glycerin, PEG/PPG-18/18 Dimethicone,

Butylene Glycol, Trimethylsiloxysilicate , Saccharide Isomerate, Tocopherol, Ascorbyl Palmitate,

Rose Extract, Caprylic/Capric Triglyceride, Octyldodecyl Neopentanoate , Ethylhexyl Palmitate,

Nylon-12, Boron Nitride, Dextrin Palmitate, Sodium Chloride, Aluminum Hydroxide, Polymethylsilsesquioxane, Glyceryl Polyacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethylmethoxy Chromanyl Palmitate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate,

Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Calcium Silicate,

Palmitic Acid, Stearic Acid, Citric Acid , Lecithin, Acrylates/Ammonium Methacrylate Copolymer,

Sodium Citrate, Triethyl Citrate , Acrylates Crosspolymer, Disteardimonium Hectorite, Xanthan Gum, Alcohol, Alcohol Denat., Methicone, Triethoxycaprylylsilane, Lysine, Potassium Chloride, Magnesium Chloride, Zinc Chloride, Sodium Hyaluronate, Sodium Dehydroacetate, Magnesium Ascorbyl Phosphate, Octyldodecanol, Potassium Sorbate, Disodium EDTA, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol May Contain (+/-):

Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Description

Octinoxate 7.5% Titanium Dioxide 5.00% Zinc Oxide 0.99%

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

Octinoxate 7.5%

Titanium Dioxide 5.00%

Zinc Oxide 0.99%


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

Aqua/Water/Eau, Dimethicone, Glycerin, PEG/PPG-18/18 Dimethicone,

Butylene Glycol, Trimethylsiloxysilicate , Saccharide Isomerate, Tocopherol, Ascorbyl Palmitate,

Rose Extract, Caprylic/Capric Triglyceride, Octyldodecyl Neopentanoate , Ethylhexyl Palmitate,

Nylon-12, Boron Nitride, Dextrin Palmitate, Sodium Chloride, Aluminum Hydroxide, Polymethylsilsesquioxane, Glyceryl Polyacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethylmethoxy Chromanyl Palmitate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate,

Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Calcium Silicate,

Palmitic Acid, Stearic Acid, Citric Acid , Lecithin, Acrylates/Ammonium Methacrylate Copolymer,

Sodium Citrate, Triethyl Citrate , Acrylates Crosspolymer, Disteardimonium Hectorite, Xanthan Gum, Alcohol, Alcohol Denat., Methicone, Triethoxycaprylylsilane, Lysine, Potassium Chloride, Magnesium Chloride, Zinc Chloride, Sodium Hyaluronate, Sodium Dehydroacetate, Magnesium Ascorbyl Phosphate, Octyldodecanol, Potassium Sorbate, Disodium EDTA, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol May Contain (+/-):

Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

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

Octinoxate 7.5%

Titanium Dioxide 5.00%

Zinc Oxide 0.99%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)