Rejuvaderm Medispa Sunscreen
FDA Label NDC 51325-100

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 Sunscreen (NDC 51325-100). 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, dosage & administration, inactive ingredient, 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 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

Label (Spfforty)

Label (Spfforty)


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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