Label: ULTRASENSITIVE TINT SPF 30- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-120-00, 68479-120-02 - Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 18, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), may decrease 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:
- at least every two 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 help 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
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Inactive ingredients
Water/Aqua, Butylene Glycol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Neopentyl Glycol Diethylhexanoate, Arachidyl Alcohol, PEG-10 Dimethicone, Dimethicone, Behenyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Stearyl Dimethicone, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Avena Sativa (Oat) Kernel Extract, Boerhavia Diffusa Root Extract, Melissa Officinalis Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Zingiber Officinale (Ginger) Root Extract, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Thymus Vulgaris (Thyme) Oil, Pelargonium Graveolens Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Oil, Bisabolol, Tocopherol, Lecithin, Panthenol, Sodium Lactate, Sodium PCA, Sorbitol, Proline, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Glycerin, Magnesium Ascorbyl Phosphate, Silica, Arachidyl Glucoside, Cetearyl Alcohol, Ceteareth-20, Sodium DNA, Ascorbyl Tetraisopalmitate, Neopentyl Glycol Diisostearate, Alumina, Methicone, Stearic Acid, Aluminum Hydroxide, Polyglyceryl-2 Dipolyhydroxy Stearate, Polyglyceryl-3 Diiostearate, Xanthan Gum, Magnesium Aluminum Silicate, Carbomer, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Iron Oxides (77491, 77492, 77499).
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ULTRASENSITIVE TINT SPF 30
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C) Arachidyl Alcohol (UNII: 1QR1QRA9BU) PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0) Dimethicone (UNII: 92RU3N3Y1O) Docosanol (UNII: 9G1OE216XY) Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458) Stearyl Dimethicone (400 MPA.S at 50C) (UNII: R327X197HY) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Camellia Oleifera Leaf (UNII: 5077EL0C60) Oat (UNII: Z6J799EAJK) Boerhavia Diffusa Root (UNII: KR0SR09KYL) Melissa Officinalis (UNII: YF70189L0N) Vitis Vinifera Seed (UNII: C34U15ICXA) Lemon Peel (UNII: 72O054U628) Centella Asiatica (UNII: 7M867G6T1U) Echinacea Purpurea (UNII: QI7G114Y98) Ginger (UNII: C5529G5JPQ) Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44) Lavender Oil (UNII: ZBP1YXW0H8) Thyme Oil (UNII: 2UK410MY6B) Geranium Oil, Algerian Type (UNII: 5Q1I94P4WG) Rosewood Oil (UNII: F2522O5L7B) Orange Oil (UNII: AKN3KSD11B) Levomenol (UNII: 24WE03BX2T) Tocopherol (UNII: R0ZB2556P8) Egg Phospholipids (UNII: 1Z74184RGV) Panthenol (UNII: WV9CM0O67Z) Sodium Lactate (UNII: TU7HW0W0QT) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Sorbitol (UNII: 506T60A25R) Proline (UNII: 9DLQ4CIU6V) Pentylene Glycol (UNII: 50C1307PZG) Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77) Glycerin (UNII: PDC6A3C0OX) Magnesium Ascorbyl Phosphate (UNII: 0R822556M5) Silicon Dioxide (UNII: ETJ7Z6XBU4) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Cetostearyl Alcohol (UNII: 2DMT128M1S) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Ascorbyl Tetraisopalmitate (UNII: 47143LT58A) Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW) Aluminum Oxide (UNII: LMI26O6933) Methicone (20 CST) (UNII: 6777U11MKT) Stearic Acid (UNII: 4ELV7Z65AP) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12) Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8) Xanthan Gum (UNII: TTV12P4NEE) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Edetate Disodium (UNII: 7FLD91C86K) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Hydroxide (UNII: 55X04QC32I) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-120-02 1 in 1 CARTON 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-120-00 2 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/14/2012 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(68479-120) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-120)
