Drug Facts

Active ingredient

Titanium Dioxide 4.65%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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 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

isocetyl myristate • methyl methacrylate crosspolymer • diisostearyl malate • copernicia cerifera (carnauba) wax\cera carnauba\cire de carnauba • polyglyceryl-2 oleate • euphorbia cerifera (candelilla) wax\candelilla cera\cire de candelilla • aluminum hydroxide • polyethylene • tocopherol • tocopheryl acetate • rosmarinus officinalis (rosemary) extract • glycine soja (soybean) oil • phaeodactylum tricornotum extract • santalum album seed extract • poria cocos sclerotium extract • sodium rna • tourmaline • dimethicone silylate • dimethicone • calcium carbonate • malachite • phytosphingosine • caprylic/capric triglyceride • allyl methacrylates crosspolymer • bisabolol • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • isopropyl titanium triisostearate • hydrogenated cottonseed oil • tin oxide • alumina • silica • [+/-mica • titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] <iln34940>

Other information

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

PRINCIPAL DISPLAY PANEL - 3.5 g Container Carton

SKINCOLOR DE LA MER™

LA MER

the radiant concealer
broad spectrum SPF 25

POIDS NET WT. .11 OZ. / 3.5 g

PRINCIPAL DISPLAY PANEL - 3.5 g Container Carton

THE RADIANT CONCEALER BROAD SPECTRUM SPF 25
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65966-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	3.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
isocetyl myristate (UNII: 69AX3BRR5N)
diisostearyl malate (UNII: QBS8A3XZGQ)
carnauba wax (UNII: R12CBM0EIZ)
candelilla wax (UNII: WL0328HX19)
aluminum hydroxide (UNII: 5QB0T2IUN0)
high density polyethylene (UNII: UG00KM4WR7)
tocopherol (UNII: R0ZB2556P8)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
rosemary (UNII: IJ67X351P9)
soybean oil (UNII: 241ATL177A)
phaeodactylum tricornutum (UNII: Y5W63E7HLV)
santalum album seed (UNII: 7RZT0U509Y)
dimethicone (UNII: 92RU3N3Y1O)
calcium carbonate (UNII: H0G9379FGK)
phytosphingosine (UNII: GIN46U9Q2Q)
medium-chain triglycerides (UNII: C9H2L21V7U)
levomenol (UNII: 24WE03BX2T)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
hydrogenated cottonseed oil (UNII: Z82Y2C65EA)
stannic oxide (UNII: KM7N50LOS6)
aluminum oxide (UNII: LMI26O6933)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:65966-015-01	1 in 1 CARTON
1		3.5 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/01/2014

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Name	Address	ID/FEI	Business Operations
Establishment
ELGC K.K.		712808195	RELABEL(65966-015) , REPACK(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(65966-015) , REPACK(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC INC		943871157	RELABEL(65966-015) , REPACK(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC LLC		959338336	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	RELABEL(65966-015) , REPACK(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
Pennsylvania Logistics Center (PALC)		078364654	REPACK(65966-015) , RELABEL(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-015)

Name	Address	ID/FEI	Business Operations
Establishment
Toshiki Pigment Company Limited		716140285	MANUFACTURE(65966-015)