BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream

Drug Labeling and Warnings

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

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

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:
          o limit time in the sun, especially from 10 a.m.–2 p.m.
          o wear long-sleeved shirts, pants, hats and sunglasses
    * children under 6 months of age: ask a doctor

INACTIVE INGREDIENTS

INGREDIENTS: WATER\AQUA\EAU [] GLYCERIN [] PEG-4 DIHEPTANOATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] CETEARYL ALCOHOL [] CETYL ALCOHOL [] GLYCERYL STEARATE [] HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] SQUALANE [] ETHYLHEXYLGLYCERIN [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] ROSMARINUS OFFICINALIS (ROSEMARY) [] ANTHEMIS NOBILIS (CHAMOMILE) [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] ANGELICA ARCHANGELICA SEED OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] PHENYL TRIMETHICONE [] DIMETHICONE [] LECITHIN [] BUTYLENE GLYCOL [] PEG-12 DIMETHICONE [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] ASTROCARYUM MURUMURU SEED BUTTER [] SORBITAN STEARATE [] POLYSORBATE 60 [] PEG-40 STEARATE [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] ALUMINA [] PROPYLENE GLYCOL STEARATE [] POLYSORBATE 20 [] ACETYL HEXAPEPTIDE-8 [] SORBITAN LAURATE [] PROPYLENE GLYCOL LAURATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] POTASSIUM SORBATE [] CHLORPHENESIN [] PHENOXYETHANOL [] LIMONENE [] CITRONELLOL [] GERANIOL [] LINALOOL [] CITRAL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL

BOBBI BROWN

EXTRA

SPF 25 TINTED MOISTURIZING BALM

BROAD SPECTRUM SPF 25

NET WT./ POIDS  NT 1 OZ/ 30 ML

DIST. BOBBI BROWN PROFESSIONAL COSMETICS

NY, NY 10022

INGREDIENTS AND APPEARANCE

BOBBI BROWN EXTRA  TINTED MOISTURIZING BALM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-814
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 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 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)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ROSEMARY (UNII: IJ67X351P9)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ANGELICA SEED OIL (UNII: 67IO7RRV7A)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-40 STEARATE (UNII: ECU18C66Q7)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
ALUMINUM OXIDE (UNII: LMI26O6933)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-814-01	1 in 1 CARTON
1	NDC: 64141-814-02	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	01/01/2004

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc		042918826	manufacture

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Northtec Keystone		943871157	manufacture, relabel, repack

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Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		205952385	manufacture

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Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		244669714	manufacture

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Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		253616536	manufacture

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Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Centre		208579636	repack, relabel

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Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	relabel, repack

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Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture

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Whitman Laboratories Ltd.		216866277	manufacture

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Aveda Corporation		071352058	manufacture

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Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center (PALC)		078364654	repack, relabel