Label: AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID- octinoxate, titanium dioxide, octisalate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69352-020-01 - Packager: AMARTEINTERNATIONAL CO., LTD.
- 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 September 26, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
cyclomethicone, water, cyclopentasiloxane, glycerin, butylene glycol, alcohol, silica, mica, cyclohexasiloxane, PEG-10 dimethicone, cetyl PEG/PPG-10/1 dimethicone, sorbitan sesquioleate, hexyl laurate, dimethicone, caviar extract, Ginkgo biloba nut extract, Phellinus linteus extract, sodium hyaluronate, elemental sulfur, Aspalathus linearis extract, Potentilla erecta root extract, Scutellaria, baicalensis root extract, human oligopeptide-1, Thymus serpyllum extract, stearic acid, alumina, isostearic acid, triethoxycaprylylsilane, stearalkonium hectorite, disodium EDTA, fragrance, phenoxyethanol, BHT - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Directions
Directions:
- apply liberally 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor
- 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 - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID
octinoxate, titanium dioxide, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69352-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 4.9 mg in 70 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 3.78 mg in 70 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 3.5 mg in 70 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.1 mg in 70 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69352-020-01 70 mL in 1 CARTON; Type 0: Not a Combination Product 10/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2014 Labeler - AMARTEINTERNATIONAL CO., LTD. (689060285) Registrant - AMARTEINTERNATIONAL CO., LTD. (689060285) Establishment Name Address ID/FEI Business Operations Cnt Dream . Co_Cheonan Plant 694699750 manufacture(69352-020)
