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

UNBLEMISH Control Broad Spectrum SPF 20 by

Drug Labeling and Warnings

UNBLEMISH Control Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields , Apex, Bentley Labs, DHL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 0.7%

Zinc Oxide 4.75%

Purpose

Sunscreen

Sunscreen

Uses

• 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

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

• 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

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 Carton Label

RODAN+FIELDS®
UNBLEMISH

4

Oil Control
Lotion

BROAD SPECTRUM SPF 20

RODAN+FIELDS®

30 mL/1 Fl. Oz.

INGREDIENTS AND APPEARANCE

UNBLEMISH CONTROL BROAD SPECTRUM SPF 20 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.7 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2060-1	1 in 1 BOX	10/06/2017
1	NDC: 14222-2060-0	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/06/2017

Labeler - Rodan & Fields (051659584)

Establishment
Name	Address	ID/FEI	Business Operations
Apex		079110793	MANUFACTURE(14222-2060)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Labs		068351753	MANUFACTURE(14222-2060)

Establishment
Name	Address	ID/FEI	Business Operations
DHL		080516357	MANUFACTURE(14222-2060)