Obagi Skintrinsiq Clarifiying Protocol Kit
FDA Label NDC 62032-909

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Obagi Cosmeceuticals Llc for the product Obagi Skintrinsiq Clarifiying Protocol (NDC 62032-909). 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 ingredient, purpose, uses, warnings, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Obagi® Medical CLENZIderm M.D.® Pore Therapy

Drug Facts

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

Obagi™ Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen

Drug Facts

Distributed by Obagi Cosmeceuticals LLC
Long Beach, CA 90806

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

  • or the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

For external use only

When Using This Product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Otc - Stop Use

Stop use and ask a doctor if irritation becomes severe.

Stop use and ask 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying this product.
  • Shake product well before use.
  • Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses

Other Information

  • store away from heat and direct sunlight
  • store at controlled room temperature: 15°–25°C (59°–77°F)
    • store at controlled room temperature: 15°C–25°C (59°F–77°F)
    • protect this product from excessive heat and direct sun

Inactive Ingredients

benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate,Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract

Questions Or Comments?

1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Otc - Purpose

Active ingredientsPurpose
Titanium dioxide 6.2%Sunscreen
Zinc oxide 15.6%Sunscreen

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Principal Display Panel - Kit Carton

SKINTRINSIQ™

CLARIFYING
PROTOCOL KIT

INCLUDES:

  • 60 Tips
  • Obagi Nu-Derm® Gentle Cleanser, 2 FL. OZ.
  • Obagi Nu-Derm® Toner, 2 FL. OZ.
  • CLENZIderm M.D.® Pore Therapy, 5 FL. OZ.
  • Obagi Hydrate® Facial Moisturizer, 1.7 OZ.
  • Obagi Sun Shield™ Mineral Broad Spectrum SPF 50 Sunscreen, 3 OZ.
  • OBAGI®

    Principal Display Panel (Kit Carton)

    Principal Display Panel (Kit Carton)

Principal Display Panel - 148 Ml Bottle Label

OBAGI®
MEDICAL

CLENZIderm M.D.®

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 FL. OZ. (148 mL)

Principal Display Panel (148 mL Bottle Label)

Principal Display Panel (148 mL Bottle Label)

Principal Display Panel - 85 G Tube Carton

OBAGI™
MEDICAL

Sun Shield
Broad
Spectrum
SPF 50

MINERAL

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

Principal Display Panel (85 g Tube Carton)

Principal Display Panel (85 g Tube Carton)

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