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

EXTRA REPAIR FOUNDATION by

Drug Labeling and Warnings

EXTRA REPAIR FOUNDATION by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder Inc., ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. 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 oocurs

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, regulary 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-sleezed 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 dicetylphosphate 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.

SPL UNCLASSIFIED SECTION

Dist. Bobbi Brown Professional Cosmetics,
New York

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
CARROT (UNII: L56Z1JK48B)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-008-01	1 in 1 CARTON
1	NDC: 64141-008-02	30 mL in 1 JAR

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
ELGC K.K.		712808195	RELABEL(64141-008) , REPACK(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(64141-008) , RELABEL(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(64141-008)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(64141-008) , RELABEL(64141-008)