Label: AMARTE NATURAL FINISH BB- titanium dioxide, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69352-010-01 - 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.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
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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
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INGREDIENTS AND APPEARANCE
AMARTE NATURAL FINISH BB
titanium dioxide, octinoxate creamProduct 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)