Rendrevie Sun Screen SPF35 PA

Dosage form: cream
Ingredients: OCTINOXATE 5.625mL in 75mL, TITANIUM DIOXIDE 3.89mL in 75mL, OCTISALATE 2.25mL in 75mL
Labeler: Cellinbio Co Ltd
NDC Code: 76173-1001

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.

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)

RENDREVIE SUN SCREEN SPF35 PA 
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76173-1001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5.625 mL  in 75 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.89 mL  in 75 mL
OCTISALATE (OCTISALATE) OCTISALATE2.25 mL  in 75 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
GLYCERIN 
DIPROPYLENE GLYCOL 
HEXYL LAURATE 
TALC 
DIMETHICONE 
DISTEARYLDIMONIUM CHLORIDE 
MAGNESIUM SULFATE ANHYDROUS 
ALGELDRATE 
ALUMINUM STEARATE 
IMIDUREA 
METHYLPARABEN 
PROPYLPARABEN 
ALOE VERA LEAF 
CHAMOMILE 
LAVANDULA ANGUSTIFOLIA FLOWER 
ASIAN GINSENG 
SQUALANE 
FERRIC OXIDE YELLOW 
BUTYLPARABEN 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Product Characteristics
Colorwhite (black, red and silver) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76173-1001-21 TUBE (TUBE) 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/FEIOperations
Cellinbio Co Ltd557803737relabel
Establishment
NameAddressID/FEIOperations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 07/2011
 
Cellinbio Co Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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