TOM FORD SOLEIL TINTED MOISTURIZER BROAD SPECTRUM SPF 30- octinoxate, octisalate, and titanium dioxide cream

TOM FORD SOLEIL TINTED MOISTURIZER BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

TOM FORD SOLEIL TINTED MOISTURIZER BROAD SPECTRUM SPF 30 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, NORTHTEC LLC, 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 7.5%	Sunscreen
Octisalate 2.0%	Sunscreen
Titanium Dioxide 5.3%	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 butylene glycol octyldodecyl neopentanoate cetyl alcohol laureth-4 ascorbyl glucoside neopentyl glycol diheptanoate polyethylene morinda citrifolia fruit extract sapindus mukorossi fruit extract lavandula angustifolia (lavender) oil cucumis sativus (cucumber) fruit extract PEG-100 stearate scutellaria baicalensis root extract helianthus annuus (sunflower) seedcake morus nigra (mulberry) root extract hydrogenated lecithin corallina officinalis extract gelidium cartilagineum extract vitis vinifera (grape) fruit extract saccharomyces lysate extract laminaria saccharina extract laminaria digitata extract sigesbeckia orientalis (st. paul's wort) extract acetyl hexapeptide-8 sucrose glycerin glycyrrhetinic acid caffeine propylene glycol diethylhexanoate lecithin isohexadecane polyglyceryl-3 beeswax whey protein\lactis protein\proteine du petit-lait dimethoxytolyl propylresorcinol acetyl glucosamine PVP/hexadecene copolymer tourmaline yeast polysaccharides caprylyl glycol yeast extract\faex\extrait de levure isostearic acid propylene glycol dicaprate hordeum vulgare (barley) extract\extrait d'orge stearic acid tromethamine acrylamide/sodium acryloyldimethyltaurate copolymer galactoarabinan nylon-12 synthetic fluorphlogopite tocopheryl linoleate/oleate sodium hyaluronate boron nitride xanthan gum polysorbate 80 silica aluminum hydroxide caesalpinia spinosa gum tin oxide disodium EDTA BHT linalool phenoxyethanol [+/- mica titanium dioxide (CI 77891) iron oxides (CI 77491) iron oxides (CI 77492) iron oxides (CI 77499)] <ILN43839>

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

TF

TOM FORD

SOLEIL TINTED MOISTURIZER
BROAD SPECTRUM SPF 30

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

INGREDIENTS AND APPEARANCE

TOM FORD SOLEIL TINTED MOISTURIZER BROAD SPECTRUM SPF 30 
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0825 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.022 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0583 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURETH-4 (UNII: 6HQ855798J)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
NONI FRUIT (UNII: 7829X3G2X5)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CUCUMBER (UNII: YY7C30VXJT)
PEG-100 STEARATE (UNII: YD01N1999R)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
MORUS NIGRA ROOT (UNII: 033456LFG1)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CORALLINA OFFICINALIS (UNII: 4004498D06)
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
WINE GRAPE (UNII: 3GOV20705G)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
ENOXOLONE (UNII: P540XA09DR)
CAFFEINE (UNII: 3G6A5W338E)
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHOXYTOLYL PROPYLRESORCINOL (UNII: 4OD5GIH1UK)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOSTEARIC ACID (UNII: X33R8U0062)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROMETHAMINE (UNII: 023C2WHX2V)
GALACTOARABINAN (UNII: SL4SX1O487)
NYLON-12 (UNII: 446U8J075B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BORON NITRIDE (UNII: 2U4T60A6YD)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
STANNIC OXIDE (UNII: KM7N50LOS6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 76398-005-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2017

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-005) , REPACK(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-005) , REPACK(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC LLC		959338336	MANUFACTURE(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-005) , REPACK(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-005)