FACE IT AURA COLOR CONTROL 32800675- octinoxate, titanium oxide and zinc oxide cream

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

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Active ingredient:
OCTINOXATE.............. 4.0%, TITANIUM DIOXIDE. 11.5% ZINC OXIDE................. 1.0%
Available from:
THEFACESHOP CO., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen Sunscreen Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
51523-675-19

FACE IT AURA COLOR CONTROL 32800675- octinoxate, titanium oxide and zinc

oxide cream

THEFACESHOP 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 Ingredients

OCTINOXATE.............. 4.0%

TITANIUM DIOXIDE. 11.5%

ZINC OXIDE................. 1.0%

Purpos e

Sunscreen

Sunscreen

Sunscreen

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.

Directions

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: Ask a doctor

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early

skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin

aging.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating.

1. Pump 1 – 2 times to release the formula.

2. After skin care, apply evenly onto face in a light tapping motion using the enclosed CC puff.

3. Do the same for the touch-ups

Other Information

Protect the product in this container from excessive heat and direct sun

May stain or damage some fabrics or surfaces

Inactive Ingredients

WATERDIPHENYLSILOXY PHENYL

TRIMETHICONECYCLOPENTASILOXANEGLYCERINCYCLOHEXASILOXANE

BUTYLENE GLYCOLBUTYLENE GLYCOL

DICAPRYLATE/DICAPRATENIACINAMIDECETYL PEG/PPG-10/1 DIMETHICONE

MALTITOLSORBITAN ISOSTEARATEOCTYLDODECANOLCAPRYLYL

METHICONETRIMETHYLSILOXYSILICATE

TRIBEHENINPENTYLENE GLYCOLPEG-10 DIMETHICONEHEXYL

LAURATEDISTEARDIMONIUM HECTORITE

MAGNESIUM SULFATEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERDIPHENYL

DIMETHICONE

VP/HEXADECENE COPOLYMERPHENOXYETHANOLMETHYL METHACRYLATE

CROSSPOLYMERMICA (CI 77019)

TRIETHOXYCAPRYLYLSILANECERESINALUMINUM HYDROXIDESODIUM

PCAUREASTEARIC ACID

ETHYLHEXYLGLYCERINADENOSINETREHALOSEPOLYQUATERNIUM-51DISODIUM

EDTADIMETHICONESODIUM

HYALURONATETRIACETINCITRUS RETICULATA (TANGERINE) PEEL

EXTRACTACHYRANTHES FAURIEI ROOT

EXTRACTACTINIDIA POLYGAMA FRUIT EXTRACTIMPERATA CYLINDRICA ROOT

EXTRACT

POLYPERFLUOROMETHYLISOPROPYL ETHEROXYGENPEG-

8CARBOMERMETHYLPARABEN

POTASSIUM SORBATEBUTYLPARABENETHYLPARABENPROPYLPARABEN

ISOBUTYLPARABENFRAGRANCE(PARFUM)IRON OXIDES (CI 77491, CI 77492, CI 77499)

Questions or comments? Call 1 (866) 638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670

COLOR CONTROLCC CREAM

AURA COLOR CONTROL

SUNSCREEN CREAM

SPF30

03 MEDIUM BEIGE

FACE IT CC CREAM is a color-controlling cream that brightens your complexion

and keeps your morning makeup intact without any darkening.

FACE it

FACE IT AURA COLOR CONTROL 32800675

octinoxate, titanium oxide and zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51523-6 75

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

2.3 g in 20 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

.2 g in 20 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

.8 g in 20 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51523-6 75-19

1 in 1 CARTON

11/20 /20 14

1

20 g in 1 CONTAINER; 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

11/20 /20 14

Labeler -

T HEFACESHOP CO., LT D. (688329416)

THEFACESHOP CO., LTD.

Registrant -

T HEFACESHOP NORT H AMERICA, INC. (620459193)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

THEFACESHOP Co ., Ltd.

6 8 8 329 416

la be l(51523-6 75)

Revised: 11/2014

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