FDA Label for Unblemish Regimen For Acne, Blemishes And Breakouts Travel Size

View Indications, Usage & Precautions

Unblemish Regimen For Acne, Blemishes And Breakouts Travel Size Product Label

The following document was submitted to the FDA by the labeler of this product Rodan & Fields, 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.

Acne Treatment Sulfur Wash



30 mL / 1.0 Fl. Oz. U.S.

Drug Facts


Active Ingredient



Sulfur 3%

Benzoyl Peroxide 2.5%


Purpose



Acne treatment

Acne treatment

Sunscreen


Uses



  • For the treatment of acne
  • Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads
    • for the treatment of acne
    • helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads
      • 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. Do not swallow. If product is swallowed, get medical help or contact a Poison Control Centre right away. Keep entirely clear of eye area. If product enters eye, rinse with water. If irritation or rash occur, discontinue use and consult your doctor. Keep out of reach of children. Use only as directed. It is recommended that prior to exposure to the sun, users cover areas where alpha-hydroxy acids (AHAs) have been applied with sunscreen. Contact of the product with the skin must be of limited frequency and duration.

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
  • do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor
    • apply only to areas with acne
      • 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
      • avoid unnecessary sun exposure and use a sunscreen
      • avoid contact with the eyes, lips, and mouth
      • avoid contact with hair and dyed fabrics, which may be bleached by this product
      • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
      • keep out of eyes. Rinse with water to remove.


Do Not Use On



  • broken skin
  • large areas of the skin
  • damaged or broken skin


Keep Out Of Reach Of Children.



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

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


Directions



  • Cover the entire affected area with a thin layer and rinse thoroughly 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 evenly to entire face with a fresh gauze pad, avoiding the eye area. Do not rinse off. Allow to dry. Use once daily and increase to twice daily as tolerated.

    • Clean the skin thoroughly before applying this product
    • Dispense 1–2 pumps from each side. Blend product evenly
    • Cover the entire affected area with a thin layer one to three times daily
    • Do not rinse product off face
    • 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
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
    • Wash hands after application to help avoid staining fabrics
      • Apply a generous amount evenly over the entire face every morning
      • Apply liberally 15 minutes before sun exposure
      • Reapply every 2 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 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

Inactive Ingredients



Water/Aqua/Eau, Sodium Laureth Sulfate, Propylene Glycol, Distearyl Phthalic Acid Amide, Lauryl Glucoside, Aloe Barbadensis Leaf Juice, Diisodecyl Adipate, Glycerin, Hydrogenated Polyisobutene, Polyacrylamide, Cetearyl Alcohol, Titanium Dioxide (CI 77891), Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Cetyl Alcohol, Magnesium Aluminum Silicate, Ceteareth-20, Laureth-7, PEG-100 Stearate, C13-14 Isoparaffin, Bisabolol, Glyceryl Stearate, Xanthan Gum, Fragrance/Parfum, Methylparaben, Glutaral, Chlorphenesin, Diazolidinyl Urea, Phenoxyethanol, Propylparaben, Citronellol, Geraniol, Limonene, Linalool, Violet 2 (CI 60725), Red 33 (CI 17200).

Water/Aqua/Eau, Ethoxydiglycol, Glycerin, Polyacrylamide, Allantoin, Niacinamide, Panthenol, Ceramide AP, Ceramide NP, Ceramide EOP, Punica Granatum Extract, Yucca Glauca Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Phytosphingosine, Cholesterol, Corn Starch Modified, C13-14 Isoparaffin, PEG-7 Glyceryl Cocoate, Disodium Oleamido MEA-Sulfosuccinate, Laureth-7, Sodium Lauroyl Lactylate, Sodium Sulfite, Xanthan Gum, Carbomer, Triethanolamine, Fragrance/Parfum, Disodium EDTA, BHT, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Benzyl Alcohol, Citronellol, Geraniol, Limonene, Linalool.

Water/Aqua/Eau, Cyclopentasiloxane, Isododecane, Pentylene Glycol, Cetearyl Alcohol, Polysilicone-11, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Azelaic Acid, Tetrahexyldecyl Ascorbate, Tocopherol, Boerhavia Diffusa Root Extract, Atelocollagen, Nordihydroguaiaretic Acid, Oleanolic Acid, Lecithin, Tropolone, PEG-60 Almond Glycerides, Glycerin, Cholesterol, Squalane, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Xanthan Gum, Polysorbate 60, Dimethiconol, Ceteth-10 Phosphate, Dicetyl Phosphate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitan Isostearate, Alumina, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Carbomer, Sodium Metabisulfite, Sodium Chondroitin Sulfate, Citric Acid, Sodium Citrate, Disodium EDTA, Fragrance/Parfum, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Methylisothiazolinone, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool.


Otc - Questions



Questions 1-888-995-5656

Questions 1-888-995-5656

Questions 1-888-995-5656


Clarifying Toner



30 mL / 1.0 Fl. Oz. U.S.

Product Details


Ingredients



Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Ethoxydiglycol, Aloe Barbadensis Leaf Juice, Glycolic Acid, Polysorbate 20, Alcohol, Sodium Hydroxide, Panthenol, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Leuconostoc/Radish Root Ferment Filtrate, Arginine, Niacinamide, Azelaic Acid, Menthyl Lactate, Atelocollagen, Zinc Phenosulfonate, Lecithin, PEG-12 Dimethicone, Benzophenone-9, Xanthan Gum, Sodium Chondrotin Sulfate, Fragrance/Parfum, Butylene Glycol, Propylene Glycol, Disodium EDTA, DMDM Hydantoin, Chlorphenesin, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool, Blue 1 (CI 42090), Red 33 (CI 17200).


Dual Intensive Acne Treatment



2 x 4 mL / 0.13 Fl. Oz. U.S.

Drug Facts


Do Not Use If You



  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop Use And Ask A Doctor If



  • irritation becomes severe

Keep Out Of Reach Of Children



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


Oil Control Lotion Broad Spectrum Spf 20



12 mL / 0.41 Fl. Oz. U.S.

Drug Facts


Active Ingredients



Titanium Dioxide 0.7%

Zinc Oxide 4.75%


Stop Use And Ask A Doctor



if rash occurs


Other Information



  • Protect this product from excessive heat and direct sun

Principal Display Panel - Rodan Fields Unblemish Acne Treatment Sulfur Wash Label



RODAN + FIELDS®
UNBLEMISH™

1 Acne Treatment Sulfur Was

Traitement nettoyant au
soufre contre l'acné


Principal Display Panel - Rodan Fields Unblemish Dual Intensive Acne Treatment Label



RODAN + FIELDS®
UNBLEMISH™

3 Dual Intensive Acne Treatment

Traitement intensif double action
contre l'acné


Principal Display Panel - Rodan Fields Unblemish Oil Control Lotion Label



RODAN + FIELDS®
UNBLEMISH™

4 Oil Control Lotion Broad Spectrum SPF 20 Sunscreen

Lotion régulatrice Écran solaire
FPS 20+ à large spectre


Principal Display Panel - Rodan Fields Unblemish Kit Label



RODAN + FIELDS®
UNBLEMISH

Regiment for Acne, Blemishes and Breakouts

Based on Multi-Med® Therapy, UNBLEMISH is a complete skincare system that combines cosmetic
and active OTC ingredients that penetrate pores where acne originates, and helps prevent
breakouts before they are visible on the skin's surface.

This 4-product Regimen was developed by Stanford-trained dermatologists Dr. Katie Rodan and
Dr. Kathy Fields.

RODAN + FIELDS®

Acne Treatment Sulfur Wash

30 mL/ 1.0 Fl.Oz. U.S.

Clarifying Toner

30 mL/ 1.0 Fl.Oz. U.S.

Dual Intensive Acne Treatment

2 x 4 mL/0.13 Fl.Oz. U.S.

Oil Control Lotion
Broad Spectrum SPF 20

12 mL/0.41 Fl.Oz. U.S.


* Please review the disclaimer below.