EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25- octinoxate, homosalate, oxybenzone, and avobenzone cream

EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. 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 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 c12-15 alkyl ethylhexanoate butyloctyl salicylate butyrospermum parkii (shea butter) propanediol cetyl alcohol cetearyl alcohol glyceryl stearate bis-diglyceryl polyacyladipate-2 polyacrylamide tocopheryl acetate neopentyl glycol diheptanoate sucrose polyethylene olea europaea (olive) fruit extract salvia sclarea (clary) extract epilobium angustifolium extract triticum vulgare (wheat bran) extract pisum sativum (pea) extract bambusa vulgaris (bamboo) extract rosmarinus officinalis (rosemary) oenothera biennis (evening primrose) oil pelargonium graveolens (geranium) flower oil citrus grandis (grapefruit) peel oil citrus aurantium amara (bitter orange) oil anthemis nobilis (chamomile) whey protein\lactis protein\proteine du petit-lait cholesterol linoleic acid caffeine acetyl hexapeptide-8 sorbitan stearate peg-40 stearate c13-14 isoparaffin caprylyl glycol dicetyl phosphate ceteth-10 phosphate laureth-7 glucosamine hcl tetrahexyldecyl ascorbate sodium hyaluronate sodium hydroxide hexylene glycol xanthan gum citric acid tetrasodium edta geraniol linalool limonene citral citronellol phenoxyethanol <iln38186>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

BOBBI BROWN
EXTRA

Repair Moisturizing Balm
Broad Spectrum SPF 25

1.7 FL. OZ./50 ml e

INGREDIENTS AND APPEARANCE

EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 
octinoxate, homosalate, oxybenzone, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
SUCROSE (UNII: C151H8M554)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CLARY SAGE (UNII: U3HSK5JC0Q)
WHEAT BRAN (UNII: 6L966A1IMR)
PEA (UNII: W4X7H8GYFM)
ROSEMARY (UNII: IJ67X351P9)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
CHAMOMILE (UNII: FGL3685T2X)
WHEY (UNII: 8617Z5FMF6)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CAFFEINE (UNII: 3G6A5W338E)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PEG-40 STEARATE (UNII: ECU18C66Q7)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
LAURETH-7 (UNII: Z95S6G8201)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-026-01	1 in 1 CARTON	08/16/2011
1		50 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	08/16/2011

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-026) , REPACK(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-026) , REPACK(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-026) , REPACK(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-026)