Your browser does not support JavaScript! EXTRA REPAIR MOISTURING BALM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

Out of scope

EXTRA REPAIR MOISTURING BALM SPF 25 (octinoxate, homosalate, oxybenzone, avobenzone) cream
[Bobbi Brown Professional Cosmetics Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] HOMOSALATE 5.00% [] OXYBENZONE 3.00% [] AVOBENZONE 2.00%

INACTIVE INGREDIENTS: WATER [] 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

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.


BOBBI BROWN


EXTRA

REPAIR MOISTURIZING

BALM SPF 25



1.7 OZ./50 ML



DISTR. BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

FOLDING CARTON

EXTRA  REPAIR MOISTURING BALM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64141-112
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLOCTYL SALICYLATE 
SHEA BUTTER 
PROPANEDIOL 
CETYL ALCOHOL 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ALPHA-TOCOPHEROL ACETATE 
NEOPENTYL GLYCOL DIHEPTANOATE 
SUCROSE 
HIGH DENSITY POLYETHYLENE 
BLACK OLIVE 
CLARY SAGE 
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
WHEAT BRAN 
PEA 
BAMBUSA VULGARIS TOP 
ROSEMARY 
EVENING PRIMROSE OIL 
PELARGONIUM GRAVEOLENS FLOWERING TOP 
CITRUS MAXIMA FRUIT RIND 
CITRUS AURANTIUM FLOWER OIL 
CHAMAEMELUM NOBILE 
WHEY 
CHOLESTEROL 
LINOLEIC ACID 
CAFFEINE 
ACETYL HEXAPEPTIDE-3 
SORBITAN MONOSTEARATE 
PEG-40 STEARATE 
C13-14 ISOPARAFFIN 
CAPRYLYL GLYCOL 
DIHEXADECYL PHOSPHATE 
CETETH-10 PHOSPHATE 
LAURETH-7 
GLUCOSAMINE HYDROCHLORIDE 
HYALURONATE SODIUM 
SODIUM HYDROXIDE 
HEXYLENE GLYCOL 
XANTHAN GUM 
CITRIC ACID MONOHYDRATE 
EDETATE SODIUM 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-112-011 in 1 CARTON
1NDC:64141-112-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/16/2011
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 9/2011
 
Bobbi Brown Professional Cosmetics Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services