TOM FORD TRACELESS FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid

TOM FORD TRACELESS FOUNDATION BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

TOM FORD TRACELESS FOUNDATION BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 2.20%	Sunscreen
Titanium Dioxide 1.5%	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 and evenly 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 phenyl trimethicone caprylyl methicone dimethicone butylene glycol isohexadecane caprylic/capric triglyceride isocetyl alcohol PEG/PPG-18/18 dimethicone magnesium sulfate PEG-10 dimethicone wheat germ glycerides sapindus mukorossi fruit extract morinda citrifolia fruit extract lavandula angustifolia (lavender) oil cholesterol caffeine glycerin simmondsia chinensis (jojoba) seed oil disteardimonium hectorite linoleic acid lecithin PEG-10 dimethicone crosspolymer cetyl PEG/PPG-10/1 dimethicone sodium hyaluronate laureth-7 tocopheryl acetate caesalpinia spinosa gum sorbitan stearate triethyl citrate triethoxycaprylylsilane pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate hydrogenated lecithin hdi/trimethylol hexyllactone crosspolymer propylene carbonate xanthan gum ascorbyl palmitate silica linalool chloroxylenol phenoxyethanol [+/- titanium dioxide (CI 77891) iron oxides (CI 77491) iron oxides (CI 77492) iron oxides (CI 77499) mica] <ILN45093>

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

TF

TOM FORD

TRACELESS FOUNDATION
BROAD SPECTRUM SPF 15

1 FL.OZ./OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

TOM FORD TRACELESS FOUNDATION BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	23.1 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15.76 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
isohexadecane (UNII: 918X1OUF1E)
medium-chain triglycerides (UNII: C9H2L21V7U)
isocetyl alcohol (UNII: 1800H64066)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
peg-10 dimethicone (600 cst) (UNII: 8PR7V1SVM0)
wheat germ oil (UNII: 14C97E680P)
sapindus mukorossi fruit (UNII: 66H9NW427Y)
noni fruit (UNII: 7829X3G2X5)
lavender oil (UNII: ZBP1YXW0H8)
cholesterol (UNII: 97C5T2UQ7J)
caffeine (UNII: 3G6A5W338E)
glycerin (UNII: PDC6A3C0OX)
jojoba oil (UNII: 724GKU717M)
disteardimonium hectorite (UNII: X687XDK09L)
linoleic acid (UNII: 9KJL21T0QJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
laureth-7 (UNII: Z95S6G8201)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
caesalpinia spinosa resin (UNII: WL3883U2PO)
sorbitan monostearate (UNII: NVZ4I0H58X)
triethyl citrate (UNII: 8Z96QXD6UM)
triethoxycaprylylsilane (UNII: LDC331P08E)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer (UNII: WB5K9Y35Y9)
propylene carbonate (UNII: 8D08K3S51E)
xanthan gum (UNII: TTV12P4NEE)
ascorbyl palmitate (UNII: QN83US2B0N)
silicon dioxide (UNII: ETJ7Z6XBU4)
linalool, (+/-)- (UNII: D81QY6I88E)
chloroxylenol (UNII: 0F32U78V2Q)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-006-01	1 in 1 CARTON	12/19/2019
1		30 mL in 1 TUBE; 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	12/19/2019

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-006) , REPACK(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-006) , REPACK(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-006) , REPACK(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-006)