UNBLEMISH CONTROL BROAD SPECTRUM SPF 20- titanium dioxide, zinc oxide lotion 
Rodan & Fields

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Titanium Dioxide 0.7%

Zinc Oxide 4.75%

Purpose

Sunscreen

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

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

Directions

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

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.

Principal Display Panel - UNBLEMISH Oil Control Lotion Tube Label

RODAN+FIELDS®
UNBLEMISH

4

Oil Control
Lotion

BROAD SPECTRUM SPF 20
SUNSCREEN

Principal Display Panel - UNBLEMISH Oil Control Lotion Tube Label

Principal Display Panel - UNBLEMISH Oil Control Lotion Carton Label

RODAN+FIELDS®
UNBLEMISH

4

Oil Control
Lotion

BROAD SPECTRUM SPF 20

RODAN+FIELDS®

30 mL/1 Fl. Oz.

Principal Display Panel - UNBLEMISH Oil Control Lotion Carton Label
UNBLEMISH CONTROL BROAD SPECTRUM SPF 20 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.7 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Isododecane (UNII: A8289P68Y2)  
Pentylene Glycol (UNII: 50C1307PZG)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Butylene Glycol (UNII: 3XUS85K0RA)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
Dimethicone (UNII: 92RU3N3Y1O)  
Azelaic Acid (UNII: F2VW3D43YT)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
Tocopherol (UNII: R0ZB2556P8)  
Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
Marine Collagen, Soluble (UNII: 8JC99XGU4W)  
Nordihydroguaiaretic Acid, (+/-)- (UNII: 7PZ73W4ZNR)  
Oleanolic Acid (UNII: 6SMK8R7TGJ)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Tropolone (UNII: 7L6DL16P1T)  
PEG-60 Almond Glycerides (UNII: 4Y0E651N0F)  
Glycerin (UNII: PDC6A3C0OX)  
Cholesterol (UNII: 97C5T2UQ7J)  
Squalane (UNII: GW89575KF9)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Xanthan Gum (UNII: TTV12P4NEE)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Dimethiconol (40 CST) (UNII: 343C7U75XW)  
Ceteth-10 Phosphate (UNII: 4E05O5N49G)  
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Sorbitan Isostearate (UNII: 01S2G2C1E4)  
Aluminum Oxide (UNII: LMI26O6933)  
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S At 1.5%) (UNII: 86FQE96TZ4)  
Carboxypolymethylene (UNII: 0A5MM307FC)  
Sodium Metabisulfite (UNII: 4VON5FNS3C)  
Sodium Chondroitin Sulfate (Porcine; 5500 MW) (UNII: H5BJH23Z9A)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Chlorphenesin (UNII: I670DAL4SZ)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
.Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
Geraniol (UNII: L837108USY)  
Limonene, (+)- (UNII: GFD7C86Q1W)  
Linalool, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-2060-11 in 1 BOX10/06/2017
1NDC:14222-2060-030 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/06/2017
Labeler - Rodan & Fields (051659584)
Establishment
NameAddressID/FEIBusiness Operations
Apex079110793MANUFACTURE(14222-2060)
Establishment
NameAddressID/FEIBusiness Operations
Bentley Labs068351753MANUFACTURE(14222-2060)
Establishment
NameAddressID/FEIBusiness Operations
DHL080516357MANUFACTURE(14222-2060)

Revised: 10/2017
Document Id: d8d1087f-b283-4aed-a5da-803fdcda87ac
Set id: cab09a20-dd7a-4662-8543-f84d33d806c5
Version: 1
Effective Time: 20171006
 
Rodan & Fields