AMARTE NATURAL FINISH BB- titanium dioxide, octinoxate cream

AMARTE NATURAL FINISH BB by

Drug Labeling and Warnings

AMARTE NATURAL FINISH BB 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: Titanium Dioxide 7.0%, Octinoxate 5.0%

INACTIVE INGREDIENT

Inactive Ingredients:
aqua, propylene glycol, cetyl ethylhexanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, Macadamia integrifolia seed oil, Argania spinosa kernel oil, oligopeptide-1, caviar extract, portulaca oleracea extract, aloe barbadensis leaf extract, althaea rosea flower extract, butyrospermum parkii butter, sulfur, allantoin, collagen, dimethicone, CI 77492, CI 77491, CI 77499, stearyl dimethicone, sorbitan sesquioleate, butylene glycol, sodium chloride, talc, phenoxyethanol, parfum

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
- use a water resistant product if swimming or sweating
- reapply 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 NATURAL FINISH BB 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69352-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.8 mg  in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69352-010-01	40 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(69352-010)