Label: UNBLEMISH CONTROL BROAD SPECTRUM SPF 20- titanium dioxide, zinc oxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 14222-2060-0, 14222-2060-1 - Packager: Rodan & Fields
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 6, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
-
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
-
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
-
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
- Principal Display Panel - UNBLEMISH Oil Control Lotion Carton Label
-
INGREDIENTS AND APPEARANCE
UNBLEMISH CONTROL BROAD SPECTRUM SPF 20
titanium dioxide, zinc oxide lotionProduct 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)
