TRACELESS TOUCH FOUNDATION BROAD SPECTRUM SPF 45 REFILL CUSHION COMPACT- titanium dioxide and zinc oxide cream

TRACELESS TOUCH FOUNDATION BROAD SPECTRUM SPF 45 REFILL CUSHION COMPACT by

Drug Labeling and Warnings

TRACELESS TOUCH FOUNDATION BROAD SPECTRUM SPF 45 REFILL CUSHION COMPACT by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, Estee Lauder Companies Inc., Nippon Shikizai,inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 7.6%
Zinc Oxide 5.1%

Purpose

Sunscreen

Use

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 at least 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 dimethicone butyloctyl salicylate octyldodecyl neopentanoate butylene glycol isononyl isononanoate lauryl peg-9 polydimethylsiloxyethyl dimethicone diethylhexyl succinate phenyl trimethicone methyl trimethicone silica dimethicone silylate tocopheryl acetate magnesium sulfate dipentaerythrityl tri-polyhydroxystearate porphyra yezoensis (algae) extract silk powder\serica\poudre de soie morinda citrifolia fruit extract sapindus mukorossi fruit extract litchi chinensis seed extract thermus thermophillus ferment caffeine glycerin lavandula angustifolia (lavender) oil citrullus vulgaris (watermelon) fruit extract lens esculenta (lentil) fruit extract laminaria saccharina extract pyrus malus (apple) fruit extract acetyl hexapeptide-8 palmaria palmata extract sodium lactate ascorbyl glucoside tourmaline caprylyl methicone cetyl peg/ppg-10/1 dimethicone caesalpinia spinosa gum hydrolyzed wheat protein/pvp crosspolymer caprylyl glycol sodium pca dimethicone/peg-10/15 crosspolymer polyhydroxystearic acid sodium hyaluronate dimethicone crosspolymer-3 triethoxycaprylylsilane laureth-4 alumina dipropylene glycol dextrin pentylene glycol citric acid linalool sodium benzoate chlorphenesin phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <iln44824>

Other information

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

PRINCIPAL DISPLAY PANEL - 12 g Jar Carton

TOM FORD

TRACELESS TOUCH FOUNDATION
BROAD SPECTRUM SPF 45 REFILL
SATIN-MATTE CUSHION COMPACT

NET WT. .42 OZ./12 g e

INGREDIENTS AND APPEARANCE

TRACELESS TOUCH FOUNDATION BROAD SPECTRUM SPF 45 REFILL CUSHION COMPACT 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	7.6 g  in 100 g
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	5.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butyloctyl salicylate (UNII: 2EH13UN8D3)
octyldodecyl neopentanoate (UNII: X8725R883T)
butylene glycol (UNII: 3XUS85K0RA)
isononyl isononanoate (UNII: S4V5BS6GCX)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
diethylhexyl succinate (UNII: 69W9UMG3P8)
phenyl trimethicone (UNII: DR0K5NOJ4R)
methyl trimethicone (UNII: S73ZQI0GXM)
silicon dioxide (UNII: ETJ7Z6XBU4)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
dipentaerythrityl tri-polyhydroxystearate (UNII: D21K655H52)
phymatolithon calcareum (UNII: 6J1M3WA0ZK)
noni fruit (UNII: 7829X3G2X5)
sapindus mukorossi fruit (UNII: 66H9NW427Y)
litchi chinensis seed (UNII: 9294024N9Q)
thermus thermophilus lysate (UNII: 775R692494)
caffeine (UNII: 3G6A5W338E)
glycerin (UNII: PDC6A3C0OX)
lavender oil (UNII: ZBP1YXW0H8)
watermelon (UNII: 231473QB6R)
lens culinaris fruit (UNII: ZYZ076G9JH)
saccharina latissima (UNII: 68CMP2MB55)
apple (UNII: B423VGH5S9)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
dulse (UNII: 7832HOY4ZQ)
sodium lactate (UNII: TU7HW0W0QT)
ascorbyl glucoside (UNII: 2V52R0NHXW)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
caesalpinia spinosa resin (UNII: WL3883U2PO)
caprylyl glycol (UNII: 00YIU5438U)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
hyaluronate sodium (UNII: YSE9PPT4TH)
triethoxycaprylylsilane (UNII: LDC331P08E)
laureth-4 (UNII: 6HQ855798J)
aluminum oxide (UNII: LMI26O6933)
dipropylene glycol (UNII: E107L85C40)
pentylene glycol (UNII: 50C1307PZG)
citric acid monohydrate (UNII: 2968PHW8QP)
linalool, (+/-)- (UNII: D81QY6I88E)
sodium benzoate (UNII: OJ245FE5EU)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-009-01	1 in 1 CARTON	03/01/2019
1		12 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2019

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-009) , REPACK(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-009) , REPACK(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-009) , REPACK(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-009)

Establishment
Name	Address	ID/FEI	Business Operations
NIPPON SHIKIZAI INC		694869178	MANUFACTURE(76398-009)