COVER 10 PERFECT FOUNDATION BE10- titanium dioxide, octinoxate, zinc oxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
F&CO Co., Ltd.
INN (International Name):
Titanium Dioxide
Composition:
Titanium Dioxide 3.98 mg in 30 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PURPOSE: Sunscreen INDICATIONS & USAGE: Shake well, pump gently, and blend effortlessly. Apply a small amount evenly over entire face. Re-apply as necessary to build desired coverage.
Authorization status:
OTC monograph not final
Authorization number:
69106-370-01

COVER 10 PERFECT FOUNDATION BE10- titanium dioxide, octinoxate, zinc oxide cream

F&CO 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 INGREDIENTS: Titanium Dioxide (CI 77891) (13.27%), Ethylhexyl Methoxycinnamate

(4.0%), Zinc Oxide (CI 77947) (0.97%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasilxoane, Methyl Trimethicone, Glycerin, Butylene

Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Trimethylsiloxysilicate,

Niacinamide, Caprylyl Methicone, Pentylene Glycol, Dimethicone, Methyl Methacrylate Crosspolymer,

Diphenylsiloxy Phenyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides

(CI 77492), Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Isostearate, Phenoxyethanol,

Tribehenin, Aluminum Hydroxide, Triethoxycaprylylsilane, Acrylates/Dimethicone Copolymer,

Polyhydroxystearic Acid, Iron Oxides (CI 77491), Dimethicone Crosspolymer, Fragrance, Stearic

Acid, Iron Oxides (CI 77499), Ethylhexyl Palmitate, Lecithin, Isostearic Acid, Isopropyl Myristate,

Ethylhexylglycerin, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Lauroyl Lysine,

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Trehalose, Lavandula Angustifolia

(Lavender) Flower Water, Polysilicone-11, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated

Lecithin, Silica Dimethyl Silylate, Copernicia Cerifera (Carnauba) Wax, Hydrogenated Lentiscus

(Mastic) Gum, Ceramide 3, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea

Extract, Citric Acid, Vanilla Plantifolia Fruit Extract, Sodium Benzoate, Sodium Hyaluronate, Potassium

Sorbate, Hexylene Glycol, Caprylhydroxamic Acid

PURPOSE

PURPOSE: Sunscreen

WARNINGS

WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on

broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not

expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

INDICATIONS & USAGE

INDICATIONS & USAGE: Shake well, pump gently, and blend effortlessly. Apply a small amount

evenly over entire face. Re-apply as necessary to build desired coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COVER 10 PERFECT FOUNDATION BE10

titanium dioxide, octinoxate, zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 10 6 -370

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

F&CO Co., Ltd.

Tita nium Dio xide (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

Titanium Dio xide

3.9 8 mg in 30 mL

O ctino xa te (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

O c tino xa te

1.20 mg in 30 mL

Zinc O xide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

0 .29 mg in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 10 6 -370 -0 1 30 mL in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 15

Labeler -

F&CO Co., Ltd. (690166186)

Registrant -

F&CO Co., Ltd. (690166186)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

F&CO Co ., Ltd.

6 9 0 16 6 18 6

ma nufa c ture (6 9 10 6 -370 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

COSMAX INC.

6 8 9 0 19 313

ma nufa c ture (6 9 10 6 -370 )

Revised: 6/2015

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