FDA Label for Rejuvaderm Medispa Sunscreen

View Indications, Usage & Precautions

Rejuvaderm Medispa Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Ellen H Frankle Md Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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.


Package Label.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


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