YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20- your name cosmetics brightening cc cream broad spectrum spf 20 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.

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DRUG FACTS

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 5.00%

Zinc Oxide 0.99%

Use

Warnings

Directions

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

Principal Display Panel

59735-160-01

YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20 
your name cosmetics brightening cc cream broad spectrum spf 20 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.99 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59735-160-011 in 1 CARTON02/21/2017
133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/21/2017
Labeler - Mana Products (078870292)

Revised: 2/2017
Document Id: 491f8925-b1e8-3372-e054-00144ff8d46c
Set id: ae6a86d2-a95b-4fa8-9676-233ef9fdc3b0
Version: 1
Effective Time: 20170222
 
Mana Products