FULL STAY CC 24HR- octinoxate, octisalate, titanium dioxide and zinc oxide cream cream

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

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Active ingredient:
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
Available from:
THEFACESHOP CO., LTD.
INN (International Name):
TITANIUM DIOXIDE
Composition:
TITANIUM DIOXIDE 2.14 g in 16 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen Sunscreen Sunscreen Sunscreen Helps prevent sunburn.
Authorization status:
OTC monograph not final
Authorization number:
51523-406-31

FULL STAY CC 24HR- octinoxate, octisalate, titanium dioxide and zinc oxide cream 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.

----------

FULL STAY CC 24 HR SUNSCREEN CREAM V201 APRICOT BEIGE SPF 50 34200406

Active Ingredients:

Octinoxate 7.0 %

Octisalate 4.5 %

Titanium Dioxide 13.4 %

Zinc Oxide 4.9 %

Purpos e

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Us es :

Helps prevent sunburn.

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.

Open the product and press the button in front once or twice. Dispense an adequate amount on the puff

and apply all over the face. Finish with a patting motion. If contents does not dispense well after the

button is pressed, shake the product gently and try again. Press the button carefully not to spurt contents.

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

May stain or damage some fabrics or surfaces.

Inactive Ingredients:

Water, Cyclopentasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Glycerin,

Niacinamide, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Methyl

Methacrylate Crosspolymer, Phenyl Trimethicone, Iron Oxides (CI 77492), Butylene Glycol,

Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Caprylyl Methicone,

Dimethicone, Tribehenin, Aluminum Hydroxide, Sorbitan Isostearate, Phenoxyethanol, Glyceryl

Tribehenate/Isostearate/Eicosandioate, Stearic Acid, Dimethicone Crosspolymer,

Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin,

Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Lauroyl Lysine, HDI/Trimethylol

Hexyllactone Crosspolymer, Rosa Damascena Flower Water, Silica, Pancratium Maritimum Extract,

Fragrance, Mica (CI 77019), 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

FULL STAY CC

24HR SUNSCREEN CREAM

V201 APRICOT BEIGE SPF 50+ PA+++

All-in-one CC leaves skin looking smooth and flawless for hours

with triple benefits of moisture + coverage + adherence and real brightening effect.

FULL STAY CC 24HR

octinoxate, octisalate, titanium dioxide and zinc oxide cream cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51523-40 6

Route of Administration

TOPICAL

THEFACESHOP CO., LTD.

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

2.14 g in 16 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

0 .72 g in 16 g

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

ZINC OXIDE

0 .78 g in 16 g

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

OCTINOXATE

1.12 g in 16 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:51523-40 6 -31 1 in 1 CARTON

10 /0 1/20 15

1

16 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

10 /0 1/20 15

Labeler -

T HEFACESHOP CO., LT D. (688329416)

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(51523-40 6 )

Revised: 9/2015

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