DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15- titanium dioxide cream

DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium dioxide 1.40%

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 the 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

isododecaneisohexadecanemethyl methacrylate crosspolymerpetrolatumglyceryl stearatedisteardimonium hectoritehydrogenated styrene/isoprene copolymermicrocrystalline wax\cera microcristallina\cire microcristallinekaolincholesterolaloe barbadensis leaf extractfusanus spicatus wood oiltocopheryl acetatelinoleic acidglycine soja (soybean) oilstearyl glycyrrhetinatebisabololsilicapropylene carbonatemethyldihydrojasmonatepolyethylene2,6-dimethyl-7-octen-2-olpolyglyceryl-3 diisostearatepentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate aluminaphenethyl alcohol[+/- iron oxides (ci 77491)iron oxides (ci 77492)iron oxides (ci 77499)titanium dioxide (ci 77891)micabismuth oxychloride (ci 77163)] <iln40794>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

ESTĒE LAUDER

Double Wear
Maximum Cover

Camouflage Makeup
for Face and Body

Broad Spectrum
SPF 15

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	0.0171 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
isododecane (UNII: A8289P68Y2)
isohexadecane (UNII: 918X1OUF1E)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: 657L0NC5MT)
petrolatum (UNII: 4T6H12BN9U)
glyceryl monostearate (UNII: 230OU9XXE4)
disteardimonium hectorite (UNII: X687XDK09L)
microcrystalline wax (UNII: XOF597Q3KY)
kaolin (UNII: 24H4NWX5CO)
cholesterol (UNII: 97C5T2UQ7J)
aloe vera leaf (UNII: ZY81Z83H0X)
santalum spicatum oil (UNII: H9LVS6REV4)
linoleic acid (UNII: 9KJL21T0QJ)
soybean oil (UNII: 241ATL177A)
stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)
levomenol (UNII: 24WE03BX2T)
silicon dioxide (UNII: ETJ7Z6XBU4)
propylene carbonate (UNII: 8D08K3S51E)
methyl dihydrojasmonate (synthetic) (UNII: 3GW44CIE3Y)
high density polyethylene (UNII: UG00KM4WR7)
dihydromyrcenol (UNII: 46L1B02ND9)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
aluminum oxide (UNII: LMI26O6933)
phenylethyl alcohol (UNII: ML9LGA7468)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
bismuth oxychloride (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-030-01	1 in 1 CARTON	10/01/2010
1		30 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	10/01/2010

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-030) , REPACK(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-030) , REPACK(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-030) , REPACK(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-030)