TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL- octinoxate, titanium dioxide, and zinc oxide cream

TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL by

Drug Labeling and Warnings

TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, Estee Lauder Companies Inc., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.0%
Titanium Dioxide 7.6%
Zinc Oxide 3.6%

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 phenyl trimethicone dimethicone pentaerythrityl tetraisostearate methyl trimethicone propanediol lauryl peg-9 polydimethylsiloxyethyl dimethicone glycerin silica isohexadecane sodium hyaluronate tocopheryl acetate acetyl hexapeptide-8 caffeine sapindus mukorossi fruit extract tremella fuciformis sporocarp extract hylocereus undatus fruit extract caprylic/capric triglyceride dimethicone/peg-10/15 crosspolymer diisostearyl malate caesalpinia spinosa gum trehalose dimethicone/vinyl dimethicone crosspolymer cetyl peg/ppg-10/1 dimethicone linoleic acid methicone triolein jojoba esters lactobacillus ferment morinda citrifolia fruit extract betaine phytosteryl canola glycerides oleic acid hydrogenated coco-glycerides alumina dimethicone silylate phospholipids magnesium sulfate trimethylsiloxysilicate lavandula angustifolia (lavender) oil triethoxycaprylylsilane disteardimonium hectorite propylene carbonate polysilicone-11 peg-75 caprylyl glycol polyglyceryl-2 triisostearate hydroxethyl urea stearyl alcohol polymethylsilsesquioxane cetearyl alcohol dipropylene glycol glyceryl stearate behenyl alcohol stearic acid butylene glycol dimethicone/divinyldimethicone silsesquioxane crosspolymer palmitic acid ammonium polyacryloyldimethyl taurate linalool tocopherol bht sodium citrate disodium edta phenoxyethanol potassium sorbate [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] <iln47200>

Other information

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

PRINCIPAL DISPLAY PANEL - 12 g Jar Carton

TF

TOM FORD

SHADE AND ILLUMINATE FOUNDATION
BROAD SPECTRUM SPF 45
SOFT RADIANCE CUSHION COMPACT REFILL
NET WT. .42 OZ./12 g e

INGREDIENTS AND APPEARANCE

TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
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	3.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
dimethicone (UNII: 92RU3N3Y1O)
pentaerythrityl tetraisostearate (UNII: 9D7IK5483F)
methyl trimethicone (UNII: S73ZQI0GXM)
propanediol (UNII: 5965N8W85T)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
isohexadecane (UNII: 918X1OUF1E)
hyaluronate sodium (UNII: YSE9PPT4TH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
caffeine (UNII: 3G6A5W338E)
sapindus mukorossi fruit (UNII: 66H9NW427Y)
tremella fuciformis fruiting body (UNII: GG8N28393G)
hylocereus undatus fruit (UNII: WUG58TD53X)
medium-chain triglycerides (UNII: C9H2L21V7U)
diisostearyl malate (UNII: QBS8A3XZGQ)
caesalpinia spinosa resin (UNII: WL3883U2PO)
trehalose (UNII: B8WCK70T7I)
linoleic acid (UNII: 9KJL21T0QJ)
methicone (20 cst) (UNII: 6777U11MKT)
glyceryl trioleate (UNII: O05EC62663)
lactobacillus reuteri (UNII: 9913I24QEE)
noni fruit (UNII: 7829X3G2X5)
betaine (UNII: 3SCV180C9W)
oleic acid (UNII: 2UMI9U37CP)
hydrogenated coco-glycerides (UNII: XDD37N2GPR)
aluminum oxide (UNII: LMI26O6933)
lecithin, soybean (UNII: 1DI56QDM62)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
lavender oil (UNII: ZBP1YXW0H8)
triethoxycaprylylsilane (UNII: LDC331P08E)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
caprylyl glycol (UNII: 00YIU5438U)
polyglyceryl-2 triisostearate (UNII: 68DUY2D39A)
hydroxyethyl urea (UNII: MBQ7DDQ7AR)
stearyl alcohol (UNII: 2KR89I4H1Y)
polymethylsilsesquioxane (4.5 microns) (UNII: 59Z907ZB69)
cetostearyl alcohol (UNII: 2DMT128M1S)
dipropylene glycol (UNII: E107L85C40)
glyceryl monostearate (UNII: 230OU9XXE4)
docosanol (UNII: 9G1OE216XY)
stearic acid (UNII: 4ELV7Z65AP)
butylene glycol (UNII: 3XUS85K0RA)
palmitic acid (UNII: 2V16EO95H1)
ammonium polyacryloyldimethyl taurate (55000 MPA.S) (UNII: F01RIY4371)
linalool, (+/-)- (UNII: D81QY6I88E)
tocopherol (UNII: R0ZB2556P8)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-011-01	1 in 1 CARTON	11/15/2019
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	11/15/2019

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-011) , REPACK(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-011) , REPACK(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-011) , REPACK(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-011)