RENDREVIE SUN SCREEN SPF35 PA - octinoxate, titanium dioxide, octisalate cream 
Cellinbio Co Ltd

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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Rendrevie Sun Screen SPF35 PA++

Drug Facts

Active ingredient

Octinoxate 7.50%
Titanium Dioxide 5.19%
Octisalate 3.00%

Purpose

Sunscreen

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.

Dosage & Administration

Helps prevent sunburn

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++

NRC Rendrevie sun sunscreen SPF35 PA++

Net WT. 2.54FL OZ(75ml)

image of carton label

RENDREVIE SUN SCREEN SPF35 PA 
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76173-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.625 mL  in 75 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.89 mL  in 75 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 mL  in 75 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (black, red and silver) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76173-1001-21 in 1 BOX
1NDC:76173-1001-175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/20/2011
Labeler - Cellinbio Co Ltd (557803737)
Registrant - Cellinbio Co Ltd (557803737)
Establishment
NameAddressID/FEIBusiness Operations
Cellinbio Co Ltd557803737relabel
Establishment
NameAddressID/FEIBusiness Operations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 7/2011
Document Id: 7c58d52c-941e-4806-8348-388e1b92c62f
Set id: a86bd118-3fd5-4d7f-8714-f94e3275e5f0
Version: 1
Effective Time: 20110720
 
Cellinbio Co Ltd