RENOVE ROYAL PERFECT COLOR CONTROL CUSHION SPF 37 / PA- titanium dioxide, zinc oxide cream 
Y.S. Health Corp.

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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Renove Royal Perfect Color Control Cushion SPF 37+ / PA++

Drug Facts

ACTIVE INGREDIENTS

Titanium Dioxide 8.14%

Zinc Oxide 6.86%

Ethylhexyl methoxycinnamate 4.0%

PURPOSE

Sunscreen

USES

WARNINGS

Do not use on

damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

     • Limit time in the sun, especially from 10 a.m.-2 p.m.

     • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

  1. Water, Cyclopentasiloxane, Butylene Glycol, Ethylhexyl Methoxycinnamate, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Cetyl PEG/PPg-10/1 Dimethicone, Talc, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Silica, Hydrogenated Polyisobutene, Mica, Niacinamide, Dipropylene Glycol Dibenzoate, Portulaca Oleracea Extract, Sorbitan Isostearate, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Centella Asiatica Extract, Iron Oxides(CI 77492), Disteardimonium Hectorite, Polymethyl Methacrylate, Sodium Chloride, Fragrance, PPG-15 Stearyl Ether Benzoate, Triethoxycaprylylsilane, Phenoxyethanol, Sorbitan Sesquioleate, Caprylic/Capric Triglyceride, Calcium Stearate, Iron Oxides(CI 77491), Nylon-12, Ethylhexylglycerin, Iron Oxides(CI 77499), Methicone, Tocopheryl Acetate, Lecithin, Polyhydroxystearic Acid, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Polyglyceryl-3 Polyricinoleate, Polyethylene, Disodium EDTA, Trimethylsiloxysilicate, Adenosine, 1,2-Hexanediol, Royal Jelly Extract

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

Product Label

Carton

RENOVE ROYAL PERFECT COLOR CONTROL CUSHION SPF 37 / PA 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60782-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE81.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE68.6 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
TALC (UNII: 7SEV7J4R1U)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
PURSLANE (UNII: M6S840WXG5)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TRICAPRIN (UNII: O1PB8EU98M)  
CALCIUM STEARATE (UNII: 776XM7047L)  
NYLON-12 (UNII: 446U8J075B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60782-002-002 in 1 BOX
115 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/04/2015
Labeler - Y.S. Health Corp. (612982504)
Registrant - Y.S. Health Corp. (612982504)

Revised: 1/2016
Document Id: 299bf476-fa58-47eb-e054-00144ff8d46c
Set id: 9855260c-6535-4d4b-850c-7a0e7a448435
Version: 4
Effective Time: 20160118
 
Y.S. Health Corp.