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

Rendrevie Sun Screen SPF35 PA by

Drug Labeling and Warnings

Rendrevie Sun Screen SPF35 PA by is a Otc medication manufactured, distributed, or labeled by Cellinbio Co Ltd, KOLMAR KOREA CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

RENDREVIE SUN SCREEN SPF35 PA 
octinoxate, titanium dioxide, octisalate cream

Product 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