BOBBI BROWN CC BROAD SPECTRUM SPF 25- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream

Bobbi Brown CC BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

Bobbi Brown CC BROAD SPECTRUM SPF 25 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.50%
Octisalate 4.00%
Oxybenzone 2.50%
Titanium Dioxide 1.10%
Zinc Oxide 3.30%

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 dimethicone butylene glycol phenyl trimethicone pentylene glycol glyceryl stearate behenyl alcohol trioctyldodecyl citrate polymethylsilsesquioxane octyldodecyl stearoyl stearate peg-40 stearate polyglyceryl-10 pentastearate pyrus malus (apple) fruit extract laminaria saccharina extract cucumis sativus (cucumber) fruit extract triticum vulgare (wheat) germ extract acetyl hexapeptide-8 scutellaria baicalensis root extract hordeum vulgare (barley) extract\ extrait d'orge polyquaternium-51 oryzanol glycyrrhetinic acid octyldodecyl neopentanoate trehalose propylene glycol laurate sucrose glycerin cholesterol caffeine sodium hyaluronate linoleic acid lecithin squalane propylene glycol stearate urea ammonium acryloyldimethyltaurate/vp copolymer polyglyceryl-6 polyricinoleate polysorbate 20 tocopheryl acetate sodium stearoyl lactylate stearic acid sorbitan laurate xanthan gum alumina sodium pca isopropyl titanium triisostearate sodium dehydroacetate triethoxycaprylylsilane disodium edta silica chlorphenesin phenoxyethanol [+/- mica ferric ferrocyanide (ci 77510) ferric ammonium ferrocyanide (ci 77510) chromium hydroxide green (ci 77289) chromium oxide greens (ci 77288) carmine (ci 75470) titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499) yellow 5 lake (ci 19140) blue 1 lake (ci 42090)] <iln40231>

other information

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

CC Cream
Broad
Spectrum
SPF 35

BOBBI
BROWN

1.35 FL. OZ./40 ml e

INGREDIENTS AND APPEARANCE

BOBBI BROWN CC BROAD SPECTRUM SPF 25 
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01199 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.03597 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
phenyl trimethicone (UNII: DR0K5NOJ4R)
pentylene glycol (UNII: 50C1307PZG)
glyceryl monostearate (UNII: 230OU9XXE4)
docosanol (UNII: 9G1OE216XY)
trioctyldodecyl citrate (UNII: 35X8CT063R)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
peg-40 stearate (UNII: ECU18C66Q7)
apple (UNII: B423VGH5S9)
saccharina latissima (UNII: 68CMP2MB55)
cucumber (UNII: YY7C30VXJT)
wheat germ (UNII: YR3G369F5A)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
gamma oryzanol (UNII: SST9XCL51M)
enoxolone (UNII: P540XA09DR)
octyldodecyl neopentanoate (UNII: X8725R883T)
trehalose (UNII: B8WCK70T7I)
propylene glycol monolaurate (UNII: 668Z5835Z3)
sucrose (UNII: C151H8M554)
glycerin (UNII: PDC6A3C0OX)
cholesterol (UNII: 97C5T2UQ7J)
caffeine (UNII: 3G6A5W338E)
hyaluronate sodium (UNII: YSE9PPT4TH)
linoleic acid (UNII: 9KJL21T0QJ)
squalane (UNII: GW89575KF9)
propylene glycol monostearate (UNII: MZM1I680W0)
urea (UNII: 8W8T17847W)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
polysorbate 20 (UNII: 7T1F30V5YH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
sodium stearoyl lactylate (UNII: IN99IT31LN)
stearic acid (UNII: 4ELV7Z65AP)
sorbitan monolaurate (UNII: 6W9PS8B71J)
xanthan gum (UNII: TTV12P4NEE)
aluminum oxide (UNII: LMI26O6933)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
sodium dehydroacetate (UNII: 8W46YN971G)
triethoxycaprylylsilane (UNII: LDC331P08E)
edetate disodium (UNII: 7FLD91C86K)
silicon dioxide (UNII: ETJ7Z6XBU4)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric ferrocyanide (UNII: TLE294X33A)
ferric ammonium ferrocyanide (UNII: 9R0NVI936I)
chromic oxide (UNII: X5Z09SU859)
carminic acid (UNII: CID8Z8N95N)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C blue no. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-018-01	1 in 1 CARTON	10/01/2013
1		40 mL in 1 TUBE; 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	10/01/2013

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-018) , REPACK(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-018) , REPACK(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-018) , REPACK(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-018)