BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25- octinoxate, homosalate, oxybenzone, and avobenzone cream

BOBBI BROWN EXTRA by

Drug Labeling and Warnings

BOBBI BROWN EXTRA by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., 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 Ingredients

Avobenzone 2.00%
Homosalate 5.00%
Octinoxate 7.50%
Oxybenzone 5.00%

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 ▪ glycerin ▪ bis-diglyceryl polyacyladipate-2 ▪ butyrospermum parkii (shea butter) ▪ peg-4 diheptanoate ▪ cetearyl alcohol ▪ cetyl alcohol ▪ glyceryl stearate ▪ hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer ▪ epilobium angustifolium extract ▪ rosmarinus officinalis (rosemary) ▪ oenothera biennis (evening primrose) oil ▪ pelargonium graveolens (geranium) flower oil ▪ angelica archangelica seed oil ▪ citrus aurantium amara (bitter orange) oil ▪ astrocaryum murumuru seed butter ▪ anthemis nobilis (chamomile) ▪ acetyl hexapeptide-8 ▪ lecithin ▪ dimethicone ▪ phenyl trimethicone ▪ propylene glycol laurate ▪ sorbitan stearate ▪ peg-40 stearate ▪ squalane ▪ ethylhexylglycerin ▪ butylene glycol ▪ dicetyl phosphate ▪ ceteth-10 phosphate ▪ polysorbate 60 ▪ peg-12 dimethicone ▪ citrus grandis (grapefruit) peel oil ▪ propylene glycol stearate ▪ sodium hyaluronate ▪ sorbitan laurate ▪ polysorbate 20 ▪ citric acid ▪ tocopheryl acetate ▪ xanthan gum ▪ alumina ▪ pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate ▪ tetrasodium edta ▪ limonene ▪ linalool ▪ citral ▪ geraniol ▪ citronellol ▪ potassium sorbate ▪ phenoxyethanol ▪ chlorphenesin ▪ [+/- titanium dioxide (ci 77891) ▪ iron oxides (ci 77491, ci 77492, ci 77499) ▪ mica] <iln38338>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

BOBBI BROWN
EXTRA

Repair Foundation
Broad Spectrum SPF 25

1 FL. OZ./30 ml e

INGREDIENTS AND APPEARANCE

BOBBI BROWN EXTRA   REPAIR FOUNDATION BROAD SPECTRUM SPF 25
octinoxate, homosalate, oxybenzone, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0821 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0548 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0548 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0219 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
shea butter (UNII: K49155WL9Y)
peg-4 diheptanoate (UNII: 2DQ7O61VHJ)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetyl alcohol (UNII: 936JST6JCN)
glyceryl monostearate (UNII: 230OU9XXE4)
rosemary (UNII: IJ67X351P9)
evening primrose oil (UNII: 3Q9L08K71N)
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)
angelica seed oil (UNII: 67IO7RRV7A)
citrus aurantium fruit (UNII: DQD16J2B5O)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
chamomile (UNII: FGL3685T2X)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
dimethicone (UNII: 92RU3N3Y1O)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol monolaurate (UNII: 668Z5835Z3)
sorbitan monostearate (UNII: NVZ4I0H58X)
peg-40 stearate (UNII: ECU18C66Q7)
squalane (UNII: GW89575KF9)
ethylhexylglycerin (UNII: 147D247K3P)
butylene glycol (UNII: 3XUS85K0RA)
dihexadecyl phosphate (UNII: 2V6E5WN99N)
ceteth-10 phosphate (UNII: 4E05O5N49G)
polysorbate 60 (UNII: CAL22UVI4M)
citrus maxima fruit rind oil (UNII: 8U3877WD44)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
hyaluronate sodium (UNII: YSE9PPT4TH)
sorbitan monolaurate (UNII: 6W9PS8B71J)
polysorbate 20 (UNII: 7T1F30V5YH)
citric acid monohydrate (UNII: 2968PHW8QP)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
xanthan gum (UNII: TTV12P4NEE)
aluminum oxide (UNII: LMI26O6933)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
edetate sodium (UNII: MP1J8420LU)
linalool, (+/-)- (UNII: D81QY6I88E)
citral (UNII: T7EU0O9VPP)
geraniol (UNII: L837108USY)
.beta.-citronellol, (r)- (UNII: P01OUT964K)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-015-01	1 in 1 CARTON	11/01/2010
1		30 mL in 1 JAR; 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	11/01/2010

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-015) , REPACK(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-015) , REPACK(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-015) , REPACK(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-015)