TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid

TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15 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 7.5%	Sunscreen
Titanium Dioxide 2.9%	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 phenyl trimethicone butylene glycol pentaerythrityl tetraethylhexanoate simmondsia chinensis (jojoba) seed oil petrolatum biosaccharide gum - 1 steareth-21 glyceryl stearate tocopheryl acetate sodium hyaluronate ethylhexylglycerin peg-12 dimethicone isohexadecane magnesium aluminum silicate xanthan gum lecithin aluminum hydroxide citric acid steareth-2 polymethyl methacrylate cetyl alcohol potassium stearate acrylamide/sodium acryloyldimethyltaurate copolymer polysorbate 80 caprylyl glycol lavandula angustifolia (lavender) oil linalool tocopherol phenoxyethanol bht sorbic acid disodium edta [+/-titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] <iln47202>

Other Information

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

TOM FORD
SOLEIL

GLOW TINTED MOISTURIZER
BROAD SPECTRUM SPF 15

1.7 FL. OZ./OZ. LIQ./50 ml e

INGREDIENTS AND APPEARANCE

TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	78 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
butylene glycol (UNII: 3XUS85K0RA)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
jojoba oil (UNII: 724GKU717M)
petrolatum (UNII: 4T6H12BN9U)
biosaccharide gum-1 (UNII: BB4PU4V09H)
steareth-21 (UNII: 53J3F32P58)
glyceryl monostearate (UNII: 230OU9XXE4)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
ethylhexylglycerin (UNII: 147D247K3P)
peg-12 dimethicone (300 cst) (UNII: ZEL54N6W95)
isohexadecane (UNII: 918X1OUF1E)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
xanthan gum (UNII: TTV12P4NEE)
aluminum hydroxide (UNII: 5QB0T2IUN0)
citric acid monohydrate (UNII: 2968PHW8QP)
steareth-2 (UNII: V56DFE46J5)
poly(methyl methacrylate; 450000 mw) (UNII: Z47NNT4J11)
cetyl alcohol (UNII: 936JST6JCN)
potassium stearate (UNII: 17V812XK50)
polysorbate 80 (UNII: 6OZP39ZG8H)
caprylyl glycol (UNII: 00YIU5438U)
lavender oil (UNII: ZBP1YXW0H8)
linalool, (+/-)- (UNII: D81QY6I88E)
tocopherol (UNII: R0ZB2556P8)
phenoxyethanol (UNII: HIE492ZZ3T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
sorbic acid (UNII: X045WJ989B)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
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: 76398-012-01	1 in 1 CARTON	02/21/2020
1		50 mL in 1 TUBE; 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	02/21/2020

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-012) , REPACK(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-012) , REPACK(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-012) , REPACK(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-012)