FDA Label for Rejuvaderm Medispa Body

View Indications, Usage & Precautions

Rejuvaderm Medispa Body 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 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.

Package Label.Principal Display Panel



Rejuvaderm MedispaReawaken the essence that is youBody LotionSPF 1512 fl oz (355 ml)401944skinwww.riskindoc.comwww.rejuvadermmedispa.com

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