RENOVE ROYAL PERFECT COLOR CONTROL CUSHION SPF 37 / PA- titanium dioxide, zinc oxide cream

Renove Royal Perfect Color Control Cushion SPF 37 / PA by

Drug Labeling and Warnings

Renove Royal Perfect Color Control Cushion SPF 37 / PA by is a Otc medication manufactured, distributed, or labeled by Y.S. Health Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS

Titanium Dioxide 8.14%

Zinc Oxide 6.86%

Ethylhexyl methoxycinnamate 4.0%

PURPOSE

Sunscreen

USES

• 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

Keep out of reach of children.

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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 minutes of swimming or sweating.
• Immediately after towel drying
• At least every 2 hours
• Sun protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly 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 a.m.-2 p.m.

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

• Children under 6 years of age: Ask a doctor.

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

INGREDIENTS AND APPEARANCE

RENOVE ROYAL PERFECT COLOR CONTROL CUSHION SPF 37 / PA 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60782-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	81.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	68.6 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60782-002-00	2 in 1 BOX
1		15 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/04/2015

Labeler - Y.S. Health Corp. (612982504)

Registrant - Y.S. Health Corp. (612982504)