AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID- octinoxate, titanium dioxide, octisalate, zinc oxide cream

AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID by

Drug Labeling and Warnings

AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID by is a Otc medication manufactured, distributed, or labeled by AMARTEINTERNATIONAL CO., LTD., Cnt Dream . Co_Cheonan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID 
octinoxate, titanium dioxide, octisalate, zinc oxide cream

Product 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)