Label: MINERAL TINTED MOISTURE BROAD SPECTRUM SPF 15 OIL FREE- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 57677-059-01 - Packager: AVEDA COPORATION
- 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 December 11, 2012
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), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every two 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 value 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
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Inactive Ingredients
Water/Aqua/Eau, Tricaprylyl Citrate, Phenyl Trimethicone, Jojoba Esters, Hydrogenated Lecithin, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Magnesium Aluminum Silicate, Cetyl Alcohol, Glyceryl Caprylate, Capryloyl Glycine, Salix Nigra (Willow) Bark Extract, Polygonum Cuspidatum Root Extract, Tourmaline, Decyl Glucoside, Sodium Lauroyl Lactylate, Dipotassium Glycyrrhizate, Xanthan Gum, Fragrance (Parfum), Aluminum Hydroxide, Disodium Coco-Glucoside Citrate, Sodium Gluconate, Citric Acid, [+/- Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Mica] <ILN36354>
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
MINERAL TINTED MOISTURE BROAD SPECTRUM SPF 15 OIL FREE
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57677-059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.04601 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Tricaprylyl Citrate (UNII: BXW1GAI4TA) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Glycerin (UNII: PDC6A3C0OX) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Cetyl Alcohol (UNII: 936JST6JCN) Glyceryl Caprylate (UNII: TM2TZD4G4A) Capryloyl Glycine (UNII: 8TY5YO42NJ) Salix Nigra Bark (UNII: QU52J3A5B3) Polygonum Cuspidatum Root (UNII: 7TRV45YZF7) Decyl Glucoside (UNII: Z17H97EA6Y) Sodium Lauroyl Lactylate (UNII: 7243K85WFO) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Xanthan Gum (UNII: TTV12P4NEE) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Sodium Gluconate (UNII: R6Q3791S76) Citric Acid Monohydrate (UNII: 2968PHW8QP) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57677-059-01 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/01/2012 Labeler - AVEDA COPORATION (071352058) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(57677-059) , REPACK(57677-059) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(57677-059) , RELABEL(57677-059) , REPACK(57677-059) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(57677-059) , RELABEL(57677-059) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(57677-059) , RELABEL(57677-059) , REPACK(57677-059) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(57677-059) , RELABEL(57677-059) , REPACK(57677-059) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(57677-059) , RELABEL(57677-059) , REPACK(57677-059) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(57677-059) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(57677-059) , RELABEL(57677-059)
