Label: RENDREVIE SUN SCREEN SPF35 PA- octinoxate, titanium dioxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76173-1001-1, 76173-1001-2 - Packager: Cellinbio Co Ltd
- 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 July 20, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredient
Octinoxate 7.50%
Titanium Dioxide 5.19%
Octisalate 3.00%
Keep out of Reach of Children
Keep out of reach of children
If swallowed, get medical help or contact a Posion Control Center right away.
Indication & Usage
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
Warnings
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging
For extenal 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 doctor if rash occurs.
Inactive Ingredient
Water, Cyclopentasiloxane, Glycerin, Dipropylene Glycol, Peg-10 Dimethicone, Hexyl Laurate, Talc, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Magnesium Sulfate, Aluminum Hydroxide, Aluminum Stearate, Fragrance, Imidazolidinyl Urea, Methylparaben, Propylparaben, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lavandula Angustifolia(Lavender) Extract, Panax Ginseng Root Extract, Squalane, Iron Oxides(CI 77492, CI 77491, CI 77499), Butylparaben, Methicone
- Rendrevie Sun Screen SPF35 PA++
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INGREDIENTS AND APPEARANCE
RENDREVIE SUN SCREEN SPF35 PA
octinoxate, titanium dioxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76173-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.625 mL in 75 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.89 mL in 75 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 mL in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) HEXYL LAURATE (UNII: 4CG9F9W01Q) TALC (UNII: 7SEV7J4R1U) DIMETHICONE (UNII: 92RU3N3Y1O) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) ALGELDRATE (UNII: 03J11K103C) ALUMINUM STEARATE (UNII: U6XF9NP8HM) IMIDUREA (UNII: M629807ATL) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ASIAN GINSENG (UNII: CUQ3A77YXI) SQUALANE (UNII: GW89575KF9) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BUTYLPARABEN (UNII: 3QPI1U3FV8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Product Characteristics Color white (black, red and silver) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76173-1001-2 1 in 1 BOX 1 NDC:76173-1001-1 75 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/20/2011 Labeler - Cellinbio Co Ltd (557803737) Registrant - Cellinbio Co Ltd (557803737) Establishment Name Address ID/FEI Business Operations Cellinbio Co Ltd 557803737 relabel Establishment Name Address ID/FEI Business Operations KOLMAR KOREA CO LTD 687846360 manufacture
