REJUVADERM MEDISPA SUNSCREEN- octinoxate, octisalate, zinc oxide lotion

Rejuvaderm Medispa sunscreen by

Drug Labeling and Warnings

Rejuvaderm Medispa sunscreen 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 2%                 Sunscreen

Zinc Oxide 7.5%            Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn caused by UVA/UVB exposure
• Provides high UVB protection
  

WARNINGS

Warnings

For external use only

• UV exposure from the sun increases the risk of skin cance, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.
• Stop use and ask a doctor if skin rash occurs.
• Keep out of reach of children.
• If swallowed, get medical help or contact a Poison Control Center right away.
  

DOSAGE & ADMINISTRATION

Directions

• Apply at least every 2 hours and after towel drying, swimming, or perspiring
• Children under 6 months of age: ask a doctor
• Reapply to dry skin as needed or after towel drying, swimming or sweating.
  

INACTIVE INGREDIENT

Inactive Ingredients

Water USP, Isopropyl Myristate, Octyldoceyl Neopentanoate, Caprylic/Capric Triglyceride, Cetearyl alcohol, Polysorbate 60, Diethanolamine Cetyl Phosphate, Hyaluroic Acid, Polyether-1, Galactoarabinan, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Triethoxycaprlylsilane,Sodium Hydroxide, Citric Acid, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA.

PRINCIPAL DISPLAY PANEL

Rejuvaderm Medispa

Reawaken the essence that is you

Sunscreen Lotion SPF 40

4 fl oz (120 ml)

401.944skin

www.riskindoc.com

ww.rejuvadermmedispa.com

INGREDIENTS AND APPEARANCE

REJUVADERM MEDISPA SUNSCREEN 
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51325-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	9 mL  in 120 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.4 mL  in 120 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	9 mL  in 120 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51325-100-01	120 mL in 1 TUBE

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)