Label: UNBLEMISH SHINE FREE- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14222-2130-1 - 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 February 13, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn.
- lf 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
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
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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 15or 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
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Inactive Ingredients
Water,Cyclopentasiloxane,Dimethicone, Butyloctyl Salicylate, PEG-10 Dimethicone, Pentylene Glycol, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butylene Glycol, Hexyl Laurate, Polysilicone-11, Tocopheryl Acetate, Boerhavia Diffusa Root Extract, Sodium PCA, Tetrahexyldecyl Ascorbate, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Cholesterol, Glycerin, Sorbitan Stearate, Oleanolic Acid, Polyglyceryl-4 lsostearate, Sorbitan lsostearate, Squalane, Stearic Acid, Fragrance, Alumina, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Methylcellulose Stearoxy Ether, Ammonium Polyacryloyldimethyl Taurate, Polysorbate 10, Polysorbate 60, Polysorbate 80, lsohexadecane, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Sodium Metabisulfite, Caprylyl Glycol, 1,2-Hexanediol, Chlorphenesin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol.
- Questions
- Principal Display Panel - 30 mL Carton Label
- Principal Display Panel - 30 mL Tube Label
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INGREDIENTS AND APPEARANCE
UNBLEMISH SHINE FREE
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-2130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.03 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.14 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PENTYLENE GLYCOL (UNII: 50C1307PZG) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYL LAURATE (UNII: 4CG9F9W01Q) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALUMINUM OXIDE (UNII: LMI26O6933) BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) CHLORPHENESIN (UNII: I670DAL4SZ) CHOLESTEROL (UNII: 97C5T2UQ7J) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIMETHICONOL (600000 CST) (UNII: RKI3S914RT) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOHEXADECANE (UNII: 918X1OUF1E) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) PEG-100 STEARATE (UNII: YD01N1999R) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) XANTHAN GUM (UNII: TTV12P4NEE) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-2130-1 1 in 1 CARTON 02/13/2019 1 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 02/13/2019 Labeler - Rodan & Fields (051659584)
