BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate lipstick

BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3.00%
Octinoxate 7.50%
Octisalate 3.50%

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

petrolatum ■ microcrystalline wax\cera microcristallina\cire microcristalline ■ polybutene ■ bis-diglyceryl polyacyladipate-2 ■ octyldodecyl stearoyl stearate ■ beeswax\cera alba\cire d abeille ■ octyldodecanol ■ coffea arabica (coffee) seed extract ■ aloe barbadensis leaf extract ■ triticum vulgare (wheat) germ oil ■ persea gratissima (avocado) oil ■ olea europaea (olive) fruit oil ■ ozokerite ■ cholesterol ■ tocopheryl acetate ■ phytosphingosine ■ glycine soja (soybean) oil ■ glyceryl distearate ■ ricinus communis (castor) seed oil ■ caprylyl glycol ■ oleic acid ■ palmitic acid ■ fragrance (parfum) ■ alpha-isomethyl ionone ■ geraniol ■ citronellol ■ benzyl benzoate ■ titanium dioxide (ci 77891) ■ red 6 (ci 15850) <iln39883>

Other information

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

PRINCIPAL DISPLAY PANEL - 15 g Jar Carton

BOBBI BROWN

Lip Balm
Broad Spectrum SPF 15

NET WT. .5 OZ./15 g e

INGREDIENTS AND APPEARANCE

BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, and octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
petrolatum (UNII: 4T6H12BN9U)
microcrystalline wax (UNII: XOF597Q3KY)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
yellow wax (UNII: 2ZA36H0S2V)
octyldodecanol (UNII: 461N1O614Y)
arabica coffee bean (UNII: 3SW678MX72)
aloe vera leaf (UNII: ZY81Z83H0X)
wheat germ oil (UNII: 14C97E680P)
avocado oil (UNII: 6VNO72PFC1)
olive oil (UNII: 6UYK2W1W1E)
cholesterol (UNII: 97C5T2UQ7J)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phytosphingosine (UNII: GIN46U9Q2Q)
soybean oil (UNII: 241ATL177A)
glyceryl distearate (UNII: 73071MW2KM)
castor oil (UNII: D5340Y2I9G)
caprylyl glycol (UNII: 00YIU5438U)
oleic acid (UNII: 2UMI9U37CP)
palmitic acid (UNII: 2V16EO95H1)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
geraniol (UNII: L837108USY)
.beta.-citronellol, (r)- (UNII: P01OUT964K)
benzyl benzoate (UNII: N863NB338G)
titanium dioxide (UNII: 15FIX9V2JP)
D&C Red No. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-019-01	1 in 1 CARTON	02/01/2002
1		15 g 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	02/01/2002

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-019) , REPACK(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-019) , REPACK(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-019) , REPACK(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-019)