TOM FORD FACE PROTECT BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

TOM FORD FACE PROTECT BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

TOM FORD FACE PROTECT BROAD SPECTRUM SPF 50 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
Avobenzone 3.0%	Sunscreen
Homosalate 5.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Octocrylene 2.8%	Sunscreen
Oxybenzone 3.0%	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 butyloctyl salicylate neopentyl glycol diheptanoate aleurites moluccana (kukui) seed oil lauryl PEG-9 polydimethylsiloxyethyl dimethicone PEG-100 stearate butylene glycol glyceryl stearate dipentaerythrityl tri-polyhydroxystearate potassium cetyl phosphate algae extract laminaria ochroleuca extract scutellaria baicalensis root extract glycyrrhetinic acid caffeine caprylic/capric triglyceride cholesterol sorbitol yeast polysaccharides ethylhexylglycerin sodium hyaluronate cetyl alcohol caprylyl glycol vp/eicosene copolymer saccharide isomerate tetrahexyldecyl ascorbate tocopheryl acetate ammonium acryloyldimethyltaurate/vp copolymer stearic acid dehydroxanthan gum fragrance (parfum) sodium dehydroacetate sodium hydroxide citric acid silica disodium EDTA BHT phenoxyethanol mica titanium dioxide (CI 77891) <ILN42872>

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

TF

TOM FORD

FACE PROTECT
BROAD SPECTRUM SPF 50

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

INGREDIENTS AND APPEARANCE

TOM FORD FACE PROTECT BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	0.03105 g  in 1 mL
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	0.05175 g  in 1 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	0.05175 g  in 1 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	0.029898 g  in 1 mL
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	0.03105 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
butyloctyl salicylate (UNII: 2EH13UN8D3)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
kukui nut oil (UNII: TP11QR7B8R)
lauryl PEG-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
PEG-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
glyceryl monostearate (UNII: 230OU9XXE4)
dipentaerythrityl tri-polyhydroxystearate (UNII: D21K655H52)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
laminaria ochroleuca (UNII: 4R2124HE76)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
enoxolone (UNII: P540XA09DR)
caffeine (UNII: 3G6A5W338E)
medium-chain triglycerides (UNII: C9H2L21V7U)
cholesterol (UNII: 97C5T2UQ7J)
sorbitol (UNII: 506T60A25R)
ethylhexylglycerin (UNII: 147D247K3P)
hyaluronate sodium (UNII: YSE9PPT4TH)
cetyl alcohol (UNII: 936JST6JCN)
caprylyl glycol (UNII: 00YIU5438U)
saccharide isomerate (UNII: W8K377W98I)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
stearic acid (UNII: 4ELV7Z65AP)
dehydroxanthan gum (UNII: 63ZP7I1BQO)
sodium dehydroacetate (UNII: 8W46YN971G)
sodium hydroxide (UNII: 55X04QC32I)
citric acid monohydrate (UNII: 2968PHW8QP)
silicon dioxide (UNII: ETJ7Z6XBU4)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-004-01	1 in 1 CARTON	01/01/2017
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	01/01/2017

Labeler - TOM FORD BEAUTY DIST (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(76398-004) , REPACK(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(76398-004) , REPACK(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(76398-004) , REPACK(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(76398-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(76398-004)