Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20: Package Insert and Label Information

YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20- octinoxate, titanium dioxide and zinc oxide 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

Octinoxate 7.5%

Titanium Dioxide 5.00%

Zinc Oxide 0.99%

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

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)

Other Information

  • Protect this product form excessive heat and direct sun

Principal Display Panel

59735-160-01
(click image for full-size original)

YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20
your name cosmetics brightening cc cream broad spectrum spf 20 lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-160
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 5 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.99 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59735-160-01 1 TUBE in 1 CARTON contains a TUBE
1 33 g in 1 TUBE This package is contained within the CARTON (59735-160-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/21/2017
Labeler — Mana Products (078870292)

Revised: 02/2017 Mana Products

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