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

TRACELESS PERFECTING FOUNDATION BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

TRACELESS PERFECTING 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 Ingredient	Purpose
Octinoxate 2.90%	Sunscreen
Titanium Dioxide 1.60%	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 dimethicone cetyl PEG/PPG-10/1 dimethicone butylene glycol glycerin trimethylsiloxysilicate disteardimonium hectorite sodium chloride polyglyceryl-3 diisostearate sapindus mukurossi fruit extract morinda citrifolia fruit extract butyrospermum parkii (shea butter) lavandula angustifolia (lavender) oil caffeine dimethicone crosspolymer methicone stearic acid glyceryl oleate caesalpinia spinosa gum tocopheryl acetate tocopherol lecithin sodium dehydroacetate ascorbyl palmitate glyceryl stearate citric acid talc alumina disodium EDTA linalool phenoxyethanol [+/- iron oxides (CI 77491) iron oxides (CI 77492) titanium dioxide (CI 77891) iron oxides (CI 77499) mica] [ILN40863]

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

TOM FORD

TRACELESS PERFECTING
FOUNDATION
BROAD SPECTRUM SPF 15

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

INGREDIENTS AND APPEARANCE

TRACELESS PERFECTING FOUNDATION BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	0.03132 g  in 100 mL
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	0.01728 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
glycerin (UNII: PDC6A3C0OX)
disteardimonium hectorite (UNII: X687XDK09L)
sodium chloride (UNII: 451W47IQ8X)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
sapindus mukorossi fruit (UNII: 66H9NW427Y)
noni fruit (UNII: 7829X3G2X5)
shea butter (UNII: K49155WL9Y)
lavender oil (UNII: ZBP1YXW0H8)
caffeine (UNII: 3G6A5W338E)
stearic acid (UNII: 4ELV7Z65AP)
glyceryl oleate (UNII: 4PC054V79P)
caesalpinia spinosa resin (UNII: WL3883U2PO)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
sodium dehydroacetate (UNII: 8W46YN971G)
ascorbyl palmitate (UNII: QN83US2B0N)
glyceryl monostearate (UNII: 230OU9XXE4)
citric acid monohydrate (UNII: 2968PHW8QP)
talc (UNII: 7SEV7J4R1U)
aluminum oxide (UNII: LMI26O6933)
edetate disodium (UNII: 7FLD91C86K)
linalool, (+/-)- (UNII: D81QY6I88E)
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: 76398-003-01	1 in 1 CARTON	04/01/2014
1		30 mL in 1 BOTTLE; 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	04/01/2014

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-003) , REPACK(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-003) , REPACK(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-003) , REPACK(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-003)