FDA Label for Unblemish Regimen For Acne, Blemishes And Breakouts
View Indications, Usage & Precautions
- GENTLE EXFOLIATING ACNE WASH
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- DUAL INTENSIVE ACNE TREATMENT
- ACTIVE INGREDIENTS
- OTC - DO NOT USE
- OTHER INFORMATION
- SHINE-FREE LOTION BROAD SPECTRUM SPF 20 SUNSCREEN
- PRINCIPAL DISPLAY PANEL - KIT LABEL
- PRINCIPAL DISPLAY PANEL - GENTLE EXFOLIATING ACNE WASH TUBE LABEL
- PRINCIPAL DISPLAY PANEL - DUAL INTENSIVE ACNE TREATMENT TUBE LABEL
- PRINCIPAL DISPLAY PANEL - SHINE-FREE LOTION TUBE LABEL
Unblemish Regimen For Acne, Blemishes And Breakouts Product Label
The following document was submitted to the FDA by the labeler of this product Rodan & Fields. 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.
Gentle Exfoliating Acne Wash
125mL/4.2 Fl. Oz.U.S.
Drug Facts
Active Ingredient
Salicylic Acid 0.5%
Purpose
Acne treatment
Acne treatment
Sunscreen
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.
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.
- Rinse right away with water if it gets in eyes.
- 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.
For external use only
Otc - When Using
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.
- Rinse right away with water if it gets in eyes.
- Keep out of eyes. Rinse with water to remove.
When using this product
Otc - Stop Use
Stop and ask a doctor
- If skin irritation occurs or gets worse.
- Irritation becomes severe.
- If rash occurs.
Stop use and ask a doctor if
Stop use and ask a doctor
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.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Cover the entire affected area with a thin layer, lather and rinse thoroughly.
- 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.
- 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 even 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 liberally at least 15 minutes before sun exposure and as needed avoiding the eye area.
- Use a water-resistant sunscreen if swimming or sweating.
- Reapply every two hours. 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-sleeve shirts, pants, hats and sunglasses.
- For children under 6 months of age: ask a doctor.
Inactive Ingredients
Water, CocamidopropyI Betaine, Potassium Cocoyl Glycinate, Sodium Cocoyl Isethionate, Perlite, Lauryl Glucoside, Colloidal Sulfur, Glycerin, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Sodium Chloride, Niacinamide, Coconut Acid, Lauric Acid, Sodium Isethionate, Fragrance (Parfum), Phytosteryl/OctyIdodecyl Lauroyl Glutamate, Xanthan Gum, Tocopherol, Dextrin, Polydextrose, AmyIopectin, Potassium Hydroxide, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol, Titanium Dioxide (Cl 77891), Red 33 (Cl 17200), Violet 2 (Cl 60725)
Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MlPA-SuIfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, C13-14 Isoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool
Water, Cyclopentasiloxane, Dimethicone, Butyloctyl Salicylate, PEG-10 Dimethicone, Pentylene Glycol, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butylene Glycol, Hexyl Laurate, Polysilicone-11, Tocopheryl Acetate, Boerhavia Diffusa Root Extract, Sodium PCA, Tetrahexyldecyl Ascorbate, PEG-60 Almond Glycerides, Nordihydraguaiaretic Acid, Cholesterol, Glycerin, Sorbitan Stearate, Oleanolic Acid, Polyglyceryl-4 Isostearate, Sorbitan Isostearate, Squalane, Stearic Acid, Fragrance, Alumina, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Methylcellulose Stearoxy Ether, Ammonium, Polyacryloyldimethyl Taurate, Polysorbate 20, Polysorbate 60, Polysorbate 80, Isohexadecane, Xanthan Gum, Disodium EDTA, Sodium Metabisulfite, Caprylyl Glycol, 1,2-Hexanediol, Chlorphenesin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol
Dual Intensive Acne Treatment
2 x 22.5mL/ 2 x 0.76 Fl. Oz. U.S.
Drug Facts
Active Ingredients
Benzoyl Peroxide 2.5%
Titanium Dioxide 3%
Zinc Oxide 14%
Otc - Do Not Use
Do not use if you
- Have very sensitive skin.
- Are sensitive to benzoyl peroxide.
- Do not use on damaged or broken skin.
Other Information
Store between 15-30°C (59-86°F).
Protect the product in this container from excessive heat and direct sun.
Shine-Free Lotion Broad Spectrum Spf 20 Sunscreen
Drug Facts
Principal Display Panel - Kit Label
RODAN+FIELDS
UNBLEMISH
Regimen for Adult Acne and Visible Signs of Aging
Based on Multi-Med Therapy, UNBLEMISH is a complete skincare system for adult skin that combines cosmetics and active OTC ingredients to gently and effectively treat acne and aging concerns. Powerful ingredients penetrate pores where acne originates to quickly clear blemishes and prevent future breakouts while tackling visible signs of aging.
This 4-Step Regimen was developed by Stanford-trained Dermatologist Dr. Katie Rodan and Dr.Kathy Fields.
RODAN+FIELDS
Gentle Exfoliating Acne Wash
125 mL/
4.2 Fl. Oz. U.S.
Clarifying Toner
125 mL/
4.2 Fl. Oz. U.S.
Dual Intensive Acne Treatment
2 x 22.5 mL/
2 x 0.76 Fl. Oz. U.S.
Shine-Free Lotion
Broad Spectrum SPF 20 Sunscreen
30 mL/
1.0 Fl. Oz. U.S.
Principal Display Panel - Gentle Exfoliating Acne Wash Tube Label
RODAN+FIELDS
UNBLEMISH
1 Gentle Exfoliating
Acne Wash
Principal Display Panel - Dual Intensive Acne Treatment Tube Label
RODAN+FIELDS
UNBLEMISH
3 Dual Intensive
Acne Treatment
Principal Display Panel - Shine-Free Lotion Tube Label
RODAN+FIELDS
UNBLEMISH
4 Shine-Free
Lotion
Broad Spectrum
SPF 20 Sunscreen
* Please review the disclaimer below.