Unblemish 30-day Regimen Kit
FDA Label NDC 14222-2150

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rodan & Fields for the product Unblemish 30-day Regimen (NDC 14222-2150). 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 refining acne wash, active ingredient, purpose, uses, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Refining Acne Wash

Salicylic Acid Cream Wash

Drug Facts

Active Ingredient

Salicylic acid 0.5%

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Benzoyl peroxide 2.5%

Purpose

Acne treatment

Sunscreen

Acne treatment

Uses

  • for the treatment of acne
  • helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads
  • Warnings

    For external use only

    • 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
      • for the treatment of acne
      • helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads

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.
      • 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.
      • 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

Stop Use And Ask A Doctor

if skin irritation occurs or gets worse

Keep Out Of Reach Of Children.

If swallowed, get medical help right away.

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

Directions

  • wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 30-60 seconds, avoiding all contact with eyes.
  • rinse thoroughly; pat dry
  • 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 over face at least 15 minutes before sun exposure
    • reapply at least 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 value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 AM - 2 PM
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months: ask a doctor
      • 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, as needed
      • 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
      • do not rinse product off face
      • 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

Inactive Ingredients

acrylates copolymer, water, cetyl alcohol, citronellol, cocamidopropyl betaine, coconut acid, colloidal sulfur, distearyl phthalic acid amide, ethylhexylglycerin, ext. violet 2 (Cl 60730), fragrance/parfum, geraniol, glycerin, hydrogenated polyisobutene, lauric acid, lauryl glucoside, limonene, linalool, myristic acid, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, potassium cocoate, potassium cocoyl glycinate, potassium hydroxide, propanediol, propylene glycol, red 33 (Cl 17200), sodium chloride, sodium cocoyl isethionate, sodium isethionate, titanium dioxide (Cl 77891), tocopherol, xanthan gum

benzyl alcohol, butyloctyl salicylate, C12-15 alkyl benzoate, dimethicone crosspolymer, dimethicone/bis-isobutyl PPG-20 crosspolymer, divinyldimethicone/dimethicone/phenylsilsesquioxane crosspolymer, ethylhexylglycerin, glycerin, isododecane, linoleic acid, linolenic acid, oleic acid, palmitic acid, polymethylsilsesquioxane, polysilicone-22, silica, silica silylate, stearic acid, tocopherol, vinyl dimethicone/methicone silsesquioxane crosspolymer

allantoin, aloe barbadensis leaf juice, aminomethyl propanol, aqua/eau/water, benzyl alcohol, BHT, biosaccharide gum-1, C13-14 isoalkane, carbomer, ceramide AP, ceramide EOP, ceramide NP, chamomilla recutita (matricaria) flower extract, cholesterol, citronellol, corn starch modified, disodium EDTA, ethoxydiglycol, ethylhexylglycerin, fragrance/parfum, geraniol, glycerin, laureth-7, leuconostoc/radish root ferment filtrate, limonene, linalool, niacinamide, panthenol, PEG-7 glyceryl cocoate, phenoxyethanol, phytosphingosine, polyacrylamide, punica granatum fruit extract, sodium lauroyl lactylate, xanthan gum, yucca glauca root extract

Questions?

1-888-995-5656

1-888-995-5656

1-888-995-5656

Invisible Matte Defense

Broad Spectrum SPF 30 Sunscreen

Drug Facts

Warnings

For external use only

For external use only

Do Not Use

  • on damaged or broken skin

Stop Use And Ask A Doctor If

  • if rash occurs
    • irritation becomes severe

Other Information

protect this product from excessive heat and direct sun

store 15-30°C (59-86°F)

Dual Intensive Acne Treatment

Benzoyl Peroxide Lotion

Drug Facts

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help right away.

Principal Display Panel - Kit Label

RODAN+FIELDS

UNBLEMISH
30-DAY REGIMEN
FOR ADULT ACNE

FEMALE FOUNDED

DERMATOLOGIST DEVELOPED

REFINING ACNE WASH

SALICYLIC ACID
CREAM WASH

65 ML / 2.2 FL OZ.

CLARIFYING TONER

60 ML / 2 FL. OZ.

DUAL INTENSIVE
ACNE TREATMENT

BENZOYL PEROXIDE
LOTION***

2 x10 ML / 2 x 0.33 FL. OZ.

INVISIBLE MATTE
DEFENSE

BROAD SPECTRUM SPF 30
SUNSCREEN

15 ML/0.5 FL. OZ.

Figure (Unb08 0000 01)

Figure (Unb08 0000 01)

Principal Display Panel - Refining Acne Wash Tube Label

RODAN+FIELDS

UNBLEMISH

Refining Acne Wash

Salicylic Acid
Cream Wash

1

Figure (Unb08 0000 02)

Figure (Unb08 0000 02)

Principal Display Panel - Dual Intensive Acne Treatment Bottle Label

RODAN+FIELDS

UNBLEMISH

Dual Intensive Acne Treatment

Benzoyl Peroxide
Lotion

3

Figure (Unb08 0000 03)

Figure (Unb08 0000 03)

Principal Display Panel - Invisible Matte Defense Tube Label

RODAN+FIELDS

UNBLEMISH

Invisible Matte Defense

Broad Spectrum SPF 30 Sunscreen

Gel

4

Figure (Unb08 0000 04)

Figure (Unb08 0000 04)

* Please review the disclaimer below.