REJUVADERM MEDISPA BODY- octinoxate, octisalate, oxybenzone lotion

Rejuvaderm Medispa Body by

Drug Labeling and Warnings

Rejuvaderm Medispa Body by is a Otc medication manufactured, distributed, or labeled by Ellen H Frankle MD Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients     Purpose

Octinoxate 7.5%          Sunscreen

Octisalate 5.0%           Sunscreen

Oxybenzone 3.0%      Sunscreen

INDICATIONS & USAGE

Uses

Helps prevent sunburn.

Higher SPF gives more sunburn protection.

Provides moderate protection against sunburn.

WARNINGS

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Inactive Ingredients Water (Aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclomethicone, Glyceryl Stearate, Glycerin, Ammonium Hydroxide, PEG-150  Stearate, Polyacrylamide, Cetyl alcohol, Cetearyl Alcohol, Butyrospermum Parkii (shea butter), Cholesterol, Phenozyethanol,Dimethiconol, C13-14 Isoparaffin, Methylparaben, Xanathan gum, cetearyl glucoside, Disodium EDTA, Tocopheryl acetate, Laureth-7

DOSAGE & ADMINISTRATION

Directions:

• Apply daily to cleansed body skin or as directed by your physician; avoid face.
• Apply generously before sun exposure and as needed.
  
• Children under 6 months of age: ask a doctor.

Other Information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and harmful effects of the sun.
This product is not intended for sunbathing.

PRINCIPAL DISPLAY PANEL

Rejuvaderm Medispa
Reawaken the essence that is you
Body Lotion
SPF 15
12 fl oz (355 ml)
401944skin
www.riskindoc.com
www.rejuvadermmedispa.com

INGREDIENTS AND APPEARANCE

REJUVADERM MEDISPA BODY 
octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51325-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	26.625 mL  in 355 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	17.75 mL  in 355 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	10.65 mL  in 355 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51325-200-02	355 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2010

Labeler - Ellen H Frankle MD Inc (603208240)