ALMOST MAKEUP BROAD SPECTRUM SPF 15- titanium dioxide and octinoxate powder

ALMOST MAKEUP BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

ALMOST MAKEUP BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD., ASANUMA CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Octinoxate 2.0%

Titanium Dioxide 13.0%

Purpose

Suncreen

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 suncreen 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 Spctrum 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

talc dimethicone nylon-12 silica squalane boron nitride vinyl dimethicone/methicone silsesquioxane crosspolymer cetyl caprylate diisostearyl malate phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate methicone aluminum hydroxide glycerin sodium hyaluronate magnesium palmitoyl glutamate sodium palmitoyl sarcosinate palmitoyl proline alumina tocopherol palmitic acid 1,2-hexanediol ascorbyl tetraisopalmitate tin oxide sodium dehydroacetate [+/- iron oxides (ci 77499, ci 77492, ci 77491) mica titanium dioxide (ci 77891)] [iln33273]

Other information

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

PRINCIPAL DISPLAY PANEL - 10 g Jar Carton

C

CLINIQUE

almost powder makeup
broad spectrum
SPF 15

POIDS NET WT. .35 OZ./10g e

INGREDIENTS AND APPEARANCE

ALMOST MAKEUP BROAD SPECTRUM SPF 15 
titanium dioxide and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
talc (UNII: 7SEV7J4R1U)
dimethicone (UNII: 92RU3N3Y1O)
nylon-12 (UNII: 446U8J075B)
silicon dioxide (UNII: ETJ7Z6XBU4)
squalane (UNII: GW89575KF9)
boron nitride (UNII: 2U4T60A6YD)
cetyl caprylate (UNII: 418Q5V6PLJ)
diisostearyl malate (UNII: QBS8A3XZGQ)
aluminum hydroxide (UNII: 5QB0T2IUN0)
glycerin (UNII: PDC6A3C0OX)
hyaluronate sodium (UNII: YSE9PPT4TH)
sodium palmitoyl sarcosinate (UNII: 7297LY09YF)
palmitoyl proline (UNII: I49727TDYF)
aluminum oxide (UNII: LMI26O6933)
tocopherol (UNII: R0ZB2556P8)
palmitic acid (UNII: 2V16EO95H1)
1,2-hexanediol (UNII: TR046Y3K1G)
ascorbyl tetraisopalmitate (UNII: 47143LT58A)
stannic oxide (UNII: KM7N50LOS6)
sodium dehydroacetate (UNII: 8W46YN971G)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-802-01	1 in 1 CARTON	06/01/2007
1		10 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	06/01/2007

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-802) , REPACK(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-802) , REPACK(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-802) , REPACK(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
ASANUMA CORPORATION		715464975	MANUFACTURE(49527-802)

Establishment
Name	Address	ID/FEI	Business Operations
ASANUMA CORPORATION		715464942	MANUFACTURE(49527-802)