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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ALMOST POWDER MAKEUP BROAD SPECTRUM SPF 15

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

CLINIQUE

almost powder makeup
broad spectrum
SPF 15

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

PRINCIPAL DISPLAY PANEL - 10 g Jar Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	06/01/2007	11/16/2020

Labeler - CLINIQUE LABORATORIES LLC (044475127)

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

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

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

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

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

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

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

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

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

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

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

Revised: 11/2020

Document Id: 9f917df6-6300-489e-aa5f-112e7381e08a

Set id: b077abcf-29c5-43ba-a57c-2655b977baf2

Version: 5

Effective Time: 20201116

CLINIQUE LABORATORIES LLC