STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION- octinoxate and titanium dioxide cream

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

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
MAKEUP ART COSMETICS
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
40046-0065-1

STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION- octinoxate and titanium

dioxide cream

MAKEUP ART COSMETICS

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.

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STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION

Drug Facts

Active Ingredients

Purpose

Octinoxate 7.00%

Sunscreen

Titanium Dioxide 2.00%

Sunscreen

Us e

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

For sunscreen use:

apply liberally 15 minutes before sun exposure

reapply every two hours

use a water resistant sunscreen if swimming or sweating

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 value 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-sleeved shirts, pants, hats and sunglasses

children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau, cyclopentasiloxane, glycerin, butylene glycol, octyldodecyl neopentanoate, peg/ppg-

18/18 dimethicone, polymethylsilsesquioxane, isostearic acid, c4-24 alkyl

dimethicone/divinyldimethicone crosspolymer, isononyl isononanoate, tamarindus indica seed extract,

tocopherol, tocopheryl acetate, sodium hyaluronate, haberlea rhodopensis leaf extract, beta vulgaris

(beet) root extract\beta vulgaris\extrait de racine de betterave, butyrospermum parkii (shea butter), yeast

extract\faex\extrait de levure, quercus suber bark extract, phytantriol, dextrin palmitate, dextrin

palmitate/ethylhexanoate, cellulose gum, tetrahexyldecyl ascorbate, xanthan gum, dimethicone,

methicone, propylene carbonate, sodium chloride, palmitic acid, polyglyceryl-4 isostearate, cetyl

peg/ppg-10/1 dimethicone, hexyl laurate, polymethyl methacrylate, octyldodecyl pca, disteardimonium

hectorite, stearic acid, caprylyl glycol, dipropylene glycol, phenoxyethanol, aluminum stearate,

hexylene glycol [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499),

chromium oxide greens (ci 77288)] <iln35219>

Other information

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

DIST. BY: MAKE-UP ART COSMETICS

TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 40 ML Tube Carton

STUDIO SCULPT

SPF 15

FOUNDATION

BROAD SPECTRUM

SPF 15

40 ML/1.3 US FL OZ e

STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION

octinoxate and titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:40 0 46 -0 0 6 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTINOXATE

0 .0 719 4 g in 1 mL

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

TITANIUM DIOXIDE

0 .0 227 g in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

O CTYLDO DECYL NEO PENTANO ATE (UNII: X8 725R8 8 3T)

PEG/PPG-18 /18 DIMETHICO NE (UNII: 9 H0 AO7T79 4)

PO LYMETHYLSILSESQ UIO XANE ( 4 .5 MICRO NS) (UNII: 59 Z9 0 7ZB6 9 )

ISO STEARIC ACID (UNII: X33R8 U0 0 6 2)

ISO NO NYL ISO NO NANO ATE (UNII: S4V5BS6 GCX)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

BEET (UNII: N48 7KM8 COK)

SHEA BUTTER (UNII: K49 155WL9 Y)

PHYTANTRIO L (UNII: 8 LVI0 7A72W)

DEXTRIN PALMITATE ( CO RN; 2 0 0 0 0 MW) (UNII: 8 9 B2BSF9 I3)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

XANTHAN GUM (UNII: TTV12P4NEE)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM STEARATE (UNII: U6 XF9 NP8 HM)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

MICA (UNII: V8 A1AW0 8 8 0 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

CHRO MIC O XIDE (UNII: X5Z0 9 SU8 59 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:40 0 46 -0 0 6 5-1

1 in 1 CARTON

0 9 /0 1/20 11

1

40 mL in 1 TUBE; 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 MONOGRAPH NOT FINAL part352

0 9 /0 1/20 11

Labeler -

MAKEUP ART COSMET ICS (010597206)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ESTEE LAUDER COMPANY, THE

8 28 534516

RELABEL(40 0 46 -0 0 6 5) , REPACK(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ESTEE LAUDER COSMETICS, LTD

2446 6 9 714

MANUFACTURE(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ESTEE LAUDER COSMETICS, LTD.

20 29 529 8 2

MANUFACTURE(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ESTEE LAUDER N.V.

370 151326

MANUFACTURE(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LEN-RON MANUFACTURING DIVISION OF ARAMIS INC

8 0 9 771152

MANUFACTURE(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NORTHTEC INC

9 438 71157

RELABEL(40 0 46 -0 0 6 5) , REPACK(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PADC 1

9 49 26 4774

RELABEL(40 0 46 -0 0 6 5) , REPACK(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

WHITMAN LABORATORIES, LTD.

216 8 6 6 277

MANUFACTURE(40 0 46 -0 0 6 5)

MAKEUP ART COSMETICS

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ESTEE LAUDER COSMETICS, LTD

25517558 0

MANUFACTURE(40 0 46 -0 0 6 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MANA PRODUCTS, INC

0 328 70 270

MANUFACTURE(40 0 46 -0 0 6 5)

Revised: 1/2019

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