TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, and zinc oxide liquid

TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Ensulizole 2.7%	Sunscreen
Octinoxate 6.7%	Sunscreen
Octisalate 4.5%	Sunscreen
Zinc Oxide 3.8%	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 phenyl trimethicone butylene glycol glycerin polymethylsilsesquioxane lauryl peg-9 polydimethylsiloxyethyl dimethicone hdi/ppg/polycaprolactone crosspolymer trimethylsiloxysilicate/dimethiconol crosspolymer tromethamine polysilicone-11 hexyl laurate cetyl peg/ppg-10/1 dimethicone neopentyl glycol diheptanoate hydroxyethyl urea tremella fuciformis sporocarp extract hylocereus undatus fruit extract euterpe oleracea fruit oil carapa guaianensis seed oil lavandula angustifolia (lavender) oil sapindus mukorossi fruit extract morinda citrifolia fruit extract polyglyceryl-4 isostearate copaifera officinalis (balsam copaiba) resin triolein caprylic/capric triglyceride betaine caffeine acetyl hexapeptide-8 tocopheryl acetate trehalose hydrogenated coco-glycerides caesalpinia spinosa gum trimethylsiloxysilicate polyhydroxystearic acid lecithin glyceryl stearate triethoxycaprylylsilane laureth-7 sodium chloride disteardimonium hectorite methicone linoleic acid phospholipids stearyl alcohol cetearyl alcohol ammonium polyacryloyldimethyl taurate sodium hyaluronate tocopherol triethyl citrate palmitic acid dimethicone/divinyldimethicone silsesquioxane crosspolymer phytosteryl canola glycerides stearic acid oleic acid polysorbate 80 polysorbate 20 behenyl alcohol silica linalool disodium edta bht potassium sorbate sodium dehydroacetate phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] <iln47071>

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

TOM FORD

SHADE AND ILLUMINATE
SOFT RADIANCE FOUNDATION
BROAD SPECTRUM SPF 50

1 FL. OZ./OZ. LIQ./30 ml ℮

INGREDIENTS AND APPEARANCE

TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50 
ensulizole, octinoxate, octisalate, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.0324 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0804 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.054 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0456 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
phenyl trimethicone (UNII: DR0K5NOJ4R)
butylene glycol (UNII: 3XUS85K0RA)
glycerin (UNII: PDC6A3C0OX)
polymethylsilsesquioxane (4.5 microns) (UNII: 59Z907ZB69)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
tromethamine (UNII: 023C2WHX2V)
dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
hexyl laurate (UNII: 4CG9F9W01Q)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
hydroxyethyl urea (UNII: MBQ7DDQ7AR)
tremella fuciformis fruiting body (UNII: GG8N28393G)
hylocereus undatus fruit (UNII: WUG58TD53X)
acai oil (UNII: Z0W6766A2W)
carapa guianensis seed oil (UNII: Y82418EH2I)
lavender oil (UNII: ZBP1YXW0H8)
sapindus mukorossi fruit (UNII: 66H9NW427Y)
noni fruit (UNII: 7829X3G2X5)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
copaifera officinalis resin (UNII: 1VH544O5AT)
glyceryl trioleate (UNII: O05EC62663)
medium-chain triglycerides (UNII: C9H2L21V7U)
betaine (UNII: 3SCV180C9W)
caffeine (UNII: 3G6A5W338E)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
trehalose (UNII: B8WCK70T7I)
hydrogenated coco-glycerides (UNII: XDD37N2GPR)
caesalpinia spinosa resin (UNII: WL3883U2PO)
glyceryl monostearate (UNII: 230OU9XXE4)
triethoxycaprylylsilane (UNII: LDC331P08E)
laureth-7 (UNII: Z95S6G8201)
sodium chloride (UNII: 451W47IQ8X)
disteardimonium hectorite (UNII: X687XDK09L)
methicone (20 cst) (UNII: 6777U11MKT)
linoleic acid (UNII: 9KJL21T0QJ)
lecithin, soybean (UNII: 1DI56QDM62)
stearyl alcohol (UNII: 2KR89I4H1Y)
cetostearyl alcohol (UNII: 2DMT128M1S)
ammonium polyacryloyldimethyl taurate (55000 MPA.S) (UNII: F01RIY4371)
hyaluronate sodium (UNII: YSE9PPT4TH)
tocopherol (UNII: R0ZB2556P8)
triethyl citrate (UNII: 8Z96QXD6UM)
palmitic acid (UNII: 2V16EO95H1)
stearic acid (UNII: 4ELV7Z65AP)
oleic acid (UNII: 2UMI9U37CP)
polysorbate 80 (UNII: 6OZP39ZG8H)
polysorbate 20 (UNII: 7T1F30V5YH)
docosanol (UNII: 9G1OE216XY)
silicon dioxide (UNII: ETJ7Z6XBU4)
linalool, (+/-)- (UNII: D81QY6I88E)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
potassium sorbate (UNII: 1VPU26JZZ4)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)
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: 76398-010-01	1 in 1 CARTON	10/10/2019
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	10/10/2019

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-010) , REPACK(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-010) , REPACK(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-010) , REPACK(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-010)