12 Days Of Derm-loved Skincare Kit
FDA Label NDC 14222-7000

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 12 Days Of Derm-loved Skincare (NDC 14222-7000). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Plumping Lip Oil SPF 28 Sunscreen Shades Pink & Berry

5 mL / 0.17 Fl. Oz. U.S.

Drug Facts

UNBLEMISH Dual Intensive Acne Treatment Benzoyl Peroxide Lotion*

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

Drug Facts

REDEFINE Triple Defense Cream Broad Spectrum SPF 30 Sunscreen

30 mL /1 Fl. Oz. U.S.

Drug Facts

Active Ingredients

Octinoxate 7.4%

Zinc oxide 7%

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Skin protectant

Acne treatment

Sunscreen

Uses

  • helps prevent sunburn
  • temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes
    • eczema
      • for the treatment of acne
      • helps keep skin clear of new acne blemishes, acne pimples, blackheads + 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

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

For external use only

For external use only

For external use only

Do Not Use

  • on damaged or broken skin
    • on damaged or broken skin

When Using This Product

  • keep out of eyes. Rinse with water to remove.
  • do not get into eyes

    • 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
      • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • rash occurs
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
      • irritation becomes severe
        • 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 product is swallowed, get medical help right away.

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

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

Directions

  • apply generously, covering lips completely at least 15 minutes before sun exposure. Do not apply outside of lip lines.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • apply an even layer over face and neck as needed

    • avoid eye area
    • use AM + PM
      • 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
        • every AM, apply liberally and evenly over face + neck 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 a.m.-2 p.m.
        • wear long-sleeved shirts, pants, hats and sunglasses
        • children under 6 months of age: Ask a doctor

Other Information

  • protect the product in this container from excessive heat and direct sun. Store between 59°F to 86°F.
  • store 15-30°C (59-86°F)

    protect the product in this container from excessive heat and direct sun

Inactive Ingredients

hydrogenated polyisobutene, phenyl trimethicone, ethylhexyl palmitate, dextrin palmitate, helianthus annuus (sunflower) seed oil, caprylic/capric triglyceride, glyceryl behenate, disteardimonium hectorite, dipalmitoyl hydroxyproline, BHT, C10-18 triglycerides, calcium sodium borosilicate, capsicum annuum fruit extract, glyceryl dioleate, menthol, lactic acid, linoleic acid, linolenic acid, octyldodecanol, oleic acid, palmitic acid, palmitoyl tripeptide-1, polyhydroxystearic acid, sodium hyaluronate, sorbitan isostearate, sorbitan oleate, stearic acid, synthetic fluorphlogopite, tetrahexyldecyl ascorbate, tocopherol, tocopheryl acetate, tribehenin, triolein, may contain (+/-): blue 1 lake (Cl 42090), iron oxides (Cl 77491, Cl 77492, Cl 77499), red 6 (Cl 15850), yellow 5 lake (Cl 19140)

aqua/water/eau, ascorbyl palmitate, behenic acid, butyrospermum parkii (shea) butter, C12-16 alcohols, calcium gluconate, caprooyl phytosphingosine, caprooyl sphingosine, caprylic/capric triglyceride, caprylyl glycol, ceramide AP, ceramide EOP, ceramide EOS, ceramide NP, ceramide NS, ceteareth-25, cetyl alcohol, cholesterol, curcuma wenyujin/curcuma kwangsiensis rhizome extract, cynara scolymus (artichoke) leaf extract, decyl glucoside, dimethicone, dipotassium glycyrrhizate, disodium EDTA, ethylhexylglycerin, gluconolactone, glycerin, helianthus annuus (sunflower) seed oil, hexylene glycol, hydrogenated lecithin, lecithin, maltodextrin, ophiopogon japonicus root extract, opuntia ficus-indica fruit extract, palmitic acid, panthenol, phenoxyethanol, polysilicone-11, potassium sorbate, propanediol, sodium acrylates copolymer, sodium benzoate, tocopherol, xanthan gum, yeast extract

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

1,2-hexanediol, alcohol denat., aluminum starch octenylsuccinate, water, benzoic acid, beta vulgaris (beet) root extract, biosaccharide gum-4, butylene glycol, butyloctyl salicylate, calcium gluconate, carnosine, cetearyl alcohol, cetyl ethylhexanoate, chlorphenesin, cynara scolymus (artichoke) leaf extract, dehydroacetic acid, diglycerin, dimethicone, dimethicone crosspolymer, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, fragrance/parfum, fructooligosaccharides, gluconolactone, glycerin, HDI/trimethylol hexyllactone crosspolymer, hydrogenated polyisobutene, lactic acid, methyl carboxymethylphenyl aminocarboxypropylphosphonate, methyl methacrylate crosspolymer, niacinamide, pentylene glycol, phenoxyethanol, phragmites karka extract, polyacrylate-13, polyisobutene, polysorbate 20, poria cocos extract, potassium lactate, propanediol, red 33 (Cl 17200), silica, sodium acetylated hyaluronate, sodium benzoate, sodium chloride, sodium polyacryloyldimethyl taurate, sodium stearoyl glutamate, sorbitan isostearate, tocopherol, vitis vinifera (grape) juice extract, VP/eicosene copolymer, yellow 5 (Cl 19140)

Questions?

1-888-995-5656

1-888-995-5656

1-888-995-5656

*When both lotion and gel are combined equally, Benzoyl Peroxide is 2.5%

1-888-995-5656

Soothe Moisturizing Rescue Cream

Colloidal Oatmeal Skin Protectant

12 mL/ 0.4 Fl Oz. U.S.

Drug Facts

Active Ingredient

Colloidal oatmeal 1%

Benzoyl peroxide 2.5%

Otc - Do Not Use

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Principal Display Panel – Kit Carton Lavel

R+F

Just What The Doctors Ordered Gifted

12 DAYS OF DERM-LOVED SKINCARE

Principal Display Panel – Kit Carton Lavel (Adv08 0002 01)

Principal Display Panel – Kit Carton Lavel (Adv08 0002 01)

Principal Display Panel – 5 Ml Tube Label

RODAN + FIELDS

Plumping Lip Oil

Huile à Lèvres Repulpante

SPF 28/FPS 28

Lip gloss / Brillant à lèvres

5 mL/0.17 FL. Oz. U.S.

Principal Display Panel – 5 mL Tube Label (Adv08 0002 02)

Principal Display Panel – 5 mL Tube Label (Adv08 0002 02)

Principal Display Panel - 12 Ml Tube Label

RODAN+FIELDS

SOOTHE 3

Moisturizing Rescue Cream

Colloidal Oatmeal

Skin Protectant

Principal Display Panel (12 mL Tube Label)

Principal Display Panel (12 mL Tube Label)

Principal Display Panel - 8 Ml Bottle Label

RODAN+FIELDS

UNBLEMISH

Dual Intensive Acne Treatment

Benzoyl Peroxide Lotion

3

Principal Display Panel (8 mL Bottle Label)

Principal Display Panel (8 mL Bottle Label)

Principal Display Panel - 30 Ml Jar Label

RODAN+FIELDS

REDEFINE 3AM

Triple Defense Cream Broad Spectrum SPF 30

Principal Display Panel (30 mL Jar Label)

Principal Display Panel (30 mL Jar Label)

* Please review the disclaimer below.