ALMOST POWDER MAKEUP BROAD SPECTRUM SPF 15

ALMOST POWDER MAKEUP BROAD SPECTRUM SPF 15

Drug Labeling and Warnings

Drug Details

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

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

C

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 49527-802
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49527-802-011 in 1 CARTON06/01/2007
110 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2007
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(49527-802) , REPACK(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(49527-802) , REPACK(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(49527-802) , REPACK(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
ASANUMA CORPORATION715464975MANUFACTURE(49527-802)
Establishment
NameAddressID/FEIBusiness Operations
ASANUMA CORPORATION715464942MANUFACTURE(49527-802)

Revised: 12/2018
 
CLINIQUE LABORATORIES INC.


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