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  5. Label Information: Obagi Skintrinsiq Clarifiying Protocol

FDA Label for Obagi Skintrinsiq Clarifiying Protocol

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. OTC - PURPOSE
    14. OTC - DO NOT USE
    15. OTC - WHEN USING
    16. PRINCIPAL DISPLAY PANEL - KIT CARTON
    17. PRINCIPAL DISPLAY PANEL - 148 ML BOTTLE LABEL
    18. PRINCIPAL DISPLAY PANEL - 85 G TUBE CARTON

Obagi Skintrinsiq Clarifiying Protocol Product Label

The following document was submitted to the FDA by the labeler of this product Obagi Cosmeceuticals Llc. 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.

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 - obagi 01

    PRINCIPAL DISPLAY PANEL - Kit Carton - obagi 01


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 - obagi 02

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label - obagi 02


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 - obagi 03

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton - obagi 03


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