Rejuvaderm Medispa Body
FDA Label NDC 51325-200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ellen H Frankle Md Inc for the product Rejuvaderm Medispa Body (NDC 51325-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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