Redness Relief Primer
FDA Label NDC 68479-009

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermalogica, Inc. for the product Redness Relief Primer (NDC 68479-009). 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 other, active ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Titanium Dioxide (3.0%),
Zinc Oxide (8.5%).

Purpose

Sunscreen

Use

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

  • if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 30 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • –limit time in the sun, especially from 10 a.m. - 2 p.m.
    • –wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Cyclopentasiloxane, Isododecane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Caprylyl Methicone, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Cross polymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Water/Aqua/Eau, Polyhydroxystearic Acid, Avena Sativa (Oat) Kernel Oil, Bisabolol, Saccharomyces Lysate Extract, Zingiber Officinale (Ginger) Root Extract, Boerhavia Diffusa Root Extract, Melia Azadirachta Seed Extract, Melia Azadirachta Leaf Extract, Avena Sativa (Oat) Kernel Extract, Amber Powder, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Ocimum Basilicum (Basil) Leaf Extract, Curcuma Longa (Tumeric) Leaf Extract, Pearl Powder, Dodecene, Hydroxyphenyl Propamidobenzoic Acid, Silica Dimethyl Silylate, Dimethicone, Butylene Glycol, Pentylene Glycol, Glycerin, Alumina, PEG-10, Stearic Acid, Triethoxycaprylylsilane, Ethylhexylglycerin, Ascorbyl Palmitate, Potassium Sorbate, Phenoxyethanol, Iron Oxides CI 77492, CI 77499.

Questions Or Comments?

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Principal Display Panel - 22 Ml Tube Carton

redness
relief
primer

spf
20
broad
spectrum

UVA medium protection

UltraCalming™

0.75 US FL OZ / 22 mL e

dermalogica®

Principal Display Panel (22 mL Tube Carton)

Principal Display Panel (22 mL Tube Carton)

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