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

BOBBI BROWN EXTRA SPF 25 TINTED BROAD SPECTRUM MOISTURIZING BALM by

Drug Labeling and Warnings

BOBBI BROWN EXTRA SPF 25 TINTED BROAD SPECTRUM MOISTURIZING BALM by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1, Len-Ron Manufacturing Division of Aramis Inc., Whitman Laboratories Ltd., Estee Lauder N.V.. 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 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] <iln38335>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

BOBBI BROWN
EXTRA

SPF 25 Tinted Moisturizing Balm
Broad Spectrum SPF 25

NET WT. 1 OZ./30 ml e

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-028
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	5 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ROSEMARY (UNII: IJ67X351P9)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ANGELICA SEED OIL (UNII: 67IO7RRV7A)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
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 MONOSTEARATE (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)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
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: 64141-028-01	1 in 1 CARTON	08/16/2011
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	08/16/2011

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-028) , REPACK(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-028) , REPACK(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-028) , REPACK(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-028)