AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID- octinoxate, titanium dioxide, octisalate, zinc oxide cream 
AMARTEINTERNATIONAL CO., LTD.

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.

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ACTIVE INGREDIENT

Active Ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 5.4%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.0%

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

PURPOSE: SUNSCREEN

WARNINGS

Warnings:
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

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

Image of carton

AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID 
octinoxate, titanium dioxide, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69352-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate4.9 mg  in 70 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.78 mg  in 70 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate3.5 mg  in 70 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.1 mg  in 70 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69352-020-0170 mL in 1 CARTON; Type 0: Not a Combination Product10/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2014
Labeler - AMARTEINTERNATIONAL CO., LTD. (689060285)
Registrant - AMARTEINTERNATIONAL CO., LTD. (689060285)
Establishment
NameAddressID/FEIBusiness Operations
Cnt Dream . Co_Cheonan Plant694699750manufacture(69352-020)

Revised: 9/2017
Document Id: e4aa261a-6314-4e03-8803-b3a1879d4969
Set id: b2b7c425-6c60-41cf-adea-9c355b24a443
Version: 2
Effective Time: 20170926
 
AMARTEINTERNATIONAL CO., LTD.