Label: RENOVE ROYAL PERFECT COLOR CONTROL CUSHION SPF 37 / PA- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60782-002-00 - Packager: Y.S. Health Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 18, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENTS
- USES
- WARNINGS
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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.
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INACTIVE INGREDIENTS
- 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
- Product Label
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INGREDIENTS AND APPEARANCE
RENOVE ROYAL PERFECT COLOR CONTROL CUSHION SPF 37 / PA
titanium dioxide, zinc oxide creamProduct 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)
