OTC Medication Information: 3CE DUO COLOR FACE BLUSH MISS FLOWER

3CE DUO COLOR FACE BLUSH MISS FLOWER- titanium dioxide powder
Nanda 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.

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 6.2%

INACTIVE INGREDIENT

Inactive Ingredients: Talc, Mica (CI 77019), Nylon-12, Silica, Octyldodecyl Stearoyl Stearate, Phenyl Trimethicone, Magnesium Myristate, Propanediol, Caprylic/Capric Triglyceride, Magnesium Stearate, Red 28 Lake (CI 45410), Triethoxycaprylylsilane, Dimethiconol Stearate, Yellow 5 Lake (CI 19140), Iron Oxides (CI 77491), Dimethicone, Methicone, Ethylhexyl Methoxycinnamate, Red 30 (CI 73360), Sodium Dehydroacetate, Tocopheryl Acetate

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION: 1. Discontinue use and consult a doctor when — your skin irritates, swells, itches, shows spots on areas applied — your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use — keep the cap closed — keep it out of children’s reach — keep it away from expose to sunlight, high and low temperatures

DESCRIPTION

INSTRUCTIONS: Achieve a beautiful flush on your skin with this pigmented blush.

Directions: With a brush, dab on the center of both cheeks then follow with spreading out by dabbing around the face line

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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3CE DUO COLOR FACE BLUSH MISS FLOWER
titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 0.31 g in 5 g
Inactive Ingredients
Ingredient Name Strength
Talc
Mica
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60764-060-02 1 CONTAINER in 1 CARTON contains a CONTAINER (60764-060-01)
1 NDC:60764-060-01 5 g in 1 CONTAINER This package is contained within the CARTON (60764-060-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/20/2016
Labeler — Nanda Co., Ltd (557816075)
Registrant — Nanda Co., Ltd (557816075)
Establishment
Name Address ID/FEI Operations
Nanda Co., Ltd 557816075 repack (60764-060)
Establishment
Name Address ID/FEI Operations
Cosmax, Inc. 689049693 manufacture (60764-060)

Revised: 10/2016 Nanda Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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