YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20 lotion

Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Your Name Cosmetics Brightening CC Cream 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

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
NYLON-12 (UNII: 446U8J075B)
BORON NITRIDE (UNII: 2U4T60A6YD)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDRIDE (UNII: KZJ3T010RQ)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
CALCIUM SILICATE (UNII: S4255P4G5M)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
XANTHAN GUM (UNII: TTV12P4NEE)
ALCOHOL (UNII: 3K9958V90M)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LYSINE (UNII: K3Z4F929H6)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
OCTYLDODECANOL (UNII: 461N1O614Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-160-01	1 in 1 CARTON	02/21/2017
1		33 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	02/21/2017

Labeler - Mana Products (078870292)