SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide lotion

SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 3.0%
Titanium Dioxide 1.6%

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 suncreen 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 suncreen 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 trimethylsiloxysilicate cetyl peg/ppg-10/1 dimethicone butylene glycol glycerin disteardimonium hectorite polyglyceryl-3 diisostearate sodium chloride laminaria saccharina extract butyrospermum parkii (shea butter) fragrance (parfum) ascorbyl palmitate tocopherol dimethicone crosspolymer methicone stearic acid tocopheryl acetate glyceryl oleate lecithin glyceryl stearate citric acid aluminum hydroxide talc disodium edta linalool sodium dehydroacetate phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <iln44078>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

BOBBI
BROWN

Skin Long-Wear Weightless
Foundation
Broad Spectrum SPF 15

Full Cover
Oil-Free Shine Control

1 FL. OZ./30 ml e

INGREDIENTS AND APPEARANCE

SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	31.65 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	16.88 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
SHEA BUTTER (UNII: K49155WL9Y)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
METHICONE (20 CST) (UNII: 6777U11MKT)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL OLEATE (UNII: 4PC054V79P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TALC (UNII: 7SEV7J4R1U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-025-01	1 in 1 CARTON	07/21/2017
1		30 mL in 1 BOTTLE; 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	07/21/2017

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-025) , REPACK(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-025) , REPACK(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-025) , REPACK(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-025)