BOBBI BROWN SPF 50 PROTECTIVE FACE BASE BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

BOBBI BROWN SPF 50 PROTECTIVE FACE BASE by

Drug Labeling and Warnings

BOBBI BROWN SPF 50 PROTECTIVE FACE BASE by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., Whitman Laboratories Ltd., Estee Lauder N.V., Estee Lauder Cosmetics Ltd., Len-Ron Manufacturing Division of Aramis Inc., PADC 1, Northtec LLC, PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3.00%
Homosalate 5.00%
Octisalate 5.00%
Octocrylene 2.70%
Oxybenzone 3.00%

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 butyloctyl salicylate methyl trimethicone neopentyl glycol diheptanoate aleurites moluccana (kukui) seed oil lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butylene glycol glyceryl stearate dipentaerythrityl tri-polyhydroxystearate laminaria ochroleuca extract laminaria digitata extract algae extract lavandula angustifolia (lavender) pelargonium graveolens (geranium) flower oil sodium hyaluronate caffeine ergothioneine sorbitol ethylhexylglycerin potassium cetyl phosphate cetyl alcohol vp/eicosene copolymer saccharide isomerate caprylic/capric triglyceride caprylyl glycol ammonium acryloyldimethyltaurate/vp copolymer stearic acid dehydroxanthan gum sodium dehydroacetate disodium edta phenoxyethanol citric acid citronellol geraniol linalool mica <iln39524>

Other information

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

SPL UNCLASSIFIED SECTION

Dist. Bobbi brown Professional Cosmetics
N.Y., N.Y., 10022

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

BOBBI
BROWN

SPF 50
PROTECTIVE
FACE BASE
BROAD
SPECTRUM
SPF 50

1.7 FL. OZ/50 ML e

INGREDIENTS AND APPEARANCE

BOBBI BROWN SPF 50 PROTECTIVE FACE BASE   BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.29124 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.04854 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.04854 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0262116 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.029124 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
methyl trimethicone (UNII: S73ZQI0GXM)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
kukui nut oil (UNII: TP11QR7B8R)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
glyceryl monostearate (UNII: 230OU9XXE4)
laminaria ochroleuca (UNII: 4R2124HE76)
laminaria digitata (UNII: 15E7C67EE8)
lavandula angustifolia subsp. angustifolia flowering top (UNII: 9YT4B71U8P)
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)
hyaluronate sodium (UNII: YSE9PPT4TH)
caffeine (UNII: 3G6A5W338E)
ergothioneine (UNII: BDZ3DQM98W)
sorbitol (UNII: 506T60A25R)
ethylhexylglycerin (UNII: 147D247K3P)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
cetyl alcohol (UNII: 936JST6JCN)
saccharide isomerate (UNII: W8K377W98I)
medium-chain triglycerides (UNII: C9H2L21V7U)
caprylyl glycol (UNII: 00YIU5438U)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
stearic acid (UNII: 4ELV7Z65AP)
sodium dehydroacetate (UNII: 8W46YN971G)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
citric acid monohydrate (UNII: 2968PHW8QP)
.beta.-citronellol, (r)- (UNII: P01OUT964K)
geraniol (UNII: L837108USY)
linalool, (+/-)- (UNII: D81QY6I88E)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-014-01	1 in 1 CARTON	09/01/2012
1		50 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	09/01/2012

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-014) , REPACK(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-014) , REPACK(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-014) , REPACK(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-014)