TOM FORD FLAWLESS GLOW FOUNDATION BROAD SPECTRUM SPF 30- octinoxate, titanium dioxide, and zinc oxide lotion

TOM FORD FLAWLESS GLOW FOUNDATION BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

TOM FORD FLAWLESS GLOW FOUNDATION 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, 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 5.0%	Sunscreen
Titanium Dioxide 3.1%	Sunscreen
Zinc Oxide 2.2%	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 methyl trimethicone phenyl trimethicone silica butyloctyl salicylate dimethicone neopentyl glycol diheptanoate c12-15 alkyl benzoate butylene glycol lauryl peg-9 polydimethylsiloxyethyl dimethicone ethylhexyl palmitate glycerin trimethylsiloxysilicate/dimethiconol crosspolymer polysilicone-11 sapindus mukorossi fruit extract caffeine lavandula angustifolia (lavender) oil thermus thermophillus ferment caesalpinia spinosa gum morinda citrifolia fruit extract sodium hyaluronate dimethicone/peg-10/15 crosspolymer peg-10 dimethicone sodium lactate sodium pca polyglutamic acid lecithin litchi chinensis seed extract laminaria saccharina extract methicone triethyl citrate tocopheryl acetate zinc stearate caprylyl glycol trimethylsiloxysilicate disteardimonium hectorite laureth-7 citrullus vulgaris (watermelon) fruit extract lens esculenta (lentil) fruit extract glycine soja (soybean) protein pyrus malus (apple) fruit extract tetrahexyldecyl ascorbate triethoxycaprylylsilane hexylene glycol xanthan gum calcium chloride sodium chloride dipropylene glycol dextrin dimethicone silylate magnesium aluminum silicate linalool silica dimethyl silylate sodium citrate disodium edta bht potassium sorbate sodium benzoate sodium dehydroacetate phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] <iln46394>

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

TOM FORD
SOLEIL

FLAWLESS GLOW FOUNDATION
BROAD SPECTRUM SPF 30

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

INGREDIENTS AND APPEARANCE

TOM FORD FLAWLESS GLOW FOUNDATION BROAD SPECTRUM SPF 30 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	0.056 g  in 100 mL
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	0.035 g  in 100 mL
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	0.024 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
phenyl trimethicone (UNII: DR0K5NOJ4R)
silicon dioxide (UNII: ETJ7Z6XBU4)
butyloctyl salicylate (UNII: 2EH13UN8D3)
dimethicone (UNII: 92RU3N3Y1O)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
butylene glycol (UNII: 3XUS85K0RA)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
ethylhexyl palmitate (UNII: 2865993309)
glycerin (UNII: PDC6A3C0OX)
caffeine (UNII: 3G6A5W338E)
lavender oil (UNII: ZBP1YXW0H8)
thermus thermophilus lysate (UNII: 775R692494)
caesalpinia spinosa resin (UNII: WL3883U2PO)
hyaluronate sodium (UNII: YSE9PPT4TH)
peg-10 dimethicone (600 CST) (UNII: 8PR7V1SVM0)
sodium lactate (UNII: TU7HW0W0QT)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
methicone (20 cst) (UNII: 6777U11MKT)
triethyl citrate (UNII: 8Z96QXD6UM)
zinc stearate (UNII: H92E6QA4FV)
caprylyl glycol (UNII: 00YIU5438U)
disteardimonium hectorite (UNII: X687XDK09L)
laureth-7 (UNII: Z95S6G8201)
watermelon (UNII: 231473QB6R)
lentil (UNII: 6O38V6B52O)
soybean (UNII: L7HT8F1ZOD)
apple (UNII: B423VGH5S9)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
triethoxycaprylylsilane (UNII: LDC331P08E)
hexylene glycol (UNII: KEH0A3F75J)
xanthan gum (UNII: TTV12P4NEE)
calcium chloride (UNII: M4I0D6VV5M)
sodium chloride (UNII: 451W47IQ8X)
dipropylene glycol (UNII: E107L85C40)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
linalool, (+/-)- (UNII: D81QY6I88E)
silica dimethyl silylate (UNII: EU2PSP0G0W)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
potassium sorbate (UNII: 1VPU26JZZ4)
sodium benzoate (UNII: OJ245FE5EU)
sodium dehydroacetate (UNII: 8W46YN971G)
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: 76398-008-01	1 in 1 CARTON	02/15/2019
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	02/15/2019

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-008) , REPACK(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-008) , REPACK(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-008) , REPACK(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-008)