TOM FORD SOLEIL GLOW TONE UP FOUNDATION BROAD SPECTRUM SPF 45- octinoxate, titanium dioxide, and zinc oxide cream

TOM FORD SOLEIL GLOW TONE UP FOUNDATION BROAD SPECTRUM SPF 45 by

Drug Labeling and Warnings

TOM FORD SOLEIL GLOW TONE UP FOUNDATION BROAD SPECTRUM SPF 45 by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, Estee Lauder Companies Inc., COSMAX INC., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, PADC 1, Len-Ron Manufacturing Division of Aramis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 4.0%

Titanium Dioxide 6.1%

Zinc Oxide 3.8%

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 octyldodecyl neopentanoate butyloctyl salicylate isononyl isononanoate methyl trimethicone diethylhexyl succinate lauryl peg-9 polydimethylsiloxyethyl dimethicone laureth-4 cetyl peg/ppg-10/1 dimethicone butylene glycol magnesium sulfate dipentaerythrityl tri-polyhydroxystearate sigesbeckia orientalis (st. paul's wort) extract glycerin lens esculenta (lentil) fruit extract pyrus malus (apple) fruit extract thermus thermophillus ferment algae extract citrullus vulgaris (watermelon) fruit extract narcissus tazetta bulb extract saccharomyces lysate extract laminaria digitata extract morinda citrifolia fruit extract whey protein\lactis protein\proteine du petit-lait chlorella vulgaris extract ergothioneine palmitoyl hexapeptide-12 polygonum cuspidatum root extract sapindus mukorossi fruit extract pearl powder acetyl hexapeptide-8 lavandula angustifolia (lavender) oil dimethicone silylate tocopheryl acetate dimethicone/peg-10/15 crosspolymer sucrose hydrolyzed wheat protein/pvp crosspolymer caprylyl glycol caffeine glyceryl polymethacrylate triethoxycaprylylsilane methicone dimethicone crosspolymer-3 sodium hyaluronate tetrahexyldecyl ascorbate disteardimonium hectorite peg-8 sodium lactate dipropylene glycol sodium pca glycine soja (soybean) protein artemia extract caesalpinia spinosa gum tin oxide silica calcium chloride alumina disodium edta linalool potassium sorbate phenoxyethanol [+/- mica iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499) bismuth oxychloride (ci 77163) titanium dioxide (ci 77891)] <iln45365>

Other information

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

PRINCIPAL DISPLAY PANEL - 12 g Jar Carton

TOM FORD
SOLEIL

GLOW TONE UP FOUNDATION
BROAD SPECTRUM SPF 45
HYDRATING CUSHION COMPACT
NET WT. .42 OZ./12 g e

INGREDIENTS AND APPEARANCE

TOM FORD SOLEIL GLOW TONE UP FOUNDATION BROAD SPECTRUM SPF 45 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	4 g  in 100 g
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	6.1 g  in 100 g
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
octyldodecyl neopentanoate (UNII: X8725R883T)
butyloctyl salicylate (UNII: 2EH13UN8D3)
isononyl isononanoate (UNII: S4V5BS6GCX)
methyl trimethicone (UNII: S73ZQI0GXM)
diethylhexyl succinate (UNII: 69W9UMG3P8)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
laureth-4 (UNII: 6HQ855798J)
butylene glycol (UNII: 3XUS85K0RA)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
dipentaerythrityl tri-polyhydroxystearate (UNII: D21K655H52)
glycerin (UNII: PDC6A3C0OX)
lentil (UNII: 6O38V6B52O)
apple (UNII: B423VGH5S9)
thermus thermophilus lysate (UNII: 775R692494)
watermelon (UNII: 231473QB6R)
whey (UNII: 8617Z5FMF6)
chlorella vulgaris (UNII: RYQ4R60M02)
ergothioneine (UNII: BDZ3DQM98W)
palmitoyl hexapeptide-12 (UNII: HO4ZT5S86C)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
lavender oil (UNII: ZBP1YXW0H8)
sucrose (UNII: C151H8M554)
caprylyl glycol (UNII: 00YIU5438U)
caffeine (UNII: 3G6A5W338E)
triethoxycaprylylsilane (UNII: LDC331P08E)
methicone (20 cst) (UNII: 6777U11MKT)
hyaluronate sodium (UNII: YSE9PPT4TH)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
disteardimonium hectorite (UNII: X687XDK09L)
polyethylene glycol 400 (UNII: B697894SGQ)
sodium lactate (UNII: TU7HW0W0QT)
dipropylene glycol (UNII: E107L85C40)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
soybean (UNII: L7HT8F1ZOD)
caesalpinia spinosa resin (UNII: WL3883U2PO)
stannic oxide (UNII: KM7N50LOS6)
silicon dioxide (UNII: ETJ7Z6XBU4)
calcium chloride (UNII: M4I0D6VV5M)
aluminum oxide (UNII: LMI26O6933)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
linalool, (+/-)- (UNII: D81QY6I88E)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
bismuth oxychloride (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-007-01	1 in 1 CARTON	02/10/2019
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	02/10/2019

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-007) , REPACK(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-007) , REPACK(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-007) , REPACK(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-007)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC.		689049693	MANUFACTURE(76398-007)