![UNBLEMISH CONTROL BROAD SPECTRUM SPF 20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RODAN & FIELDS ]](https://medic.hrt.org//dailymed/images/cab09a20-dd7a-4662-8543-f84d33d806c5/unb00-0000-01.jpg)
![UNBLEMISH CONTROL BROAD SPECTRUM SPF 20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RODAN & FIELDS ]](https://medic.hrt.org//dailymed/images/cab09a20-dd7a-4662-8543-f84d33d806c5/unb00-0000-02.jpg)
| NDC | 14222-2060-0, 14222-2060-1 |
| Set ID | cab09a20-dd7a-4662-8543-f84d33d806c5 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Rodan & Fields |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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
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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)
