CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION- avobenzone and octisalate cream

CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION by

Drug Labeling and Warnings

CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Estee Lauder N.V., Whitman Laboratories Ltd., Estee Lauder Cosmetics Ltd., Len-Ron Manufacturing Division of Aramis Inc., PADC 1, Northtec LLC, PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%
Octisalate 5%

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 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

water\aqua\eau glycerin butyloctyl salicylate polyester-8 octyldodecyl neopentanoate behenyl alcohol butylene glycol myristyl myristate cetyl esters ammonium acryloyldimethyltaurate/vp copolymer tamarindus indica seed extract plankton extract centaurium erythraea (centaury) extract sigesbeckia orientalis (st. paul's wort) extract glyceryl stearate algae extract caffeine camellia sinensis leaf extract saccharomyces ferment filtrate whey protein\lactis protein\protéine du petit-lait nylon-12 acetyl hexapeptide-8 sucrose biotin ergothioneine myristyl laurate lauryl peg-9 polydimethylsiloxyethyl dimethicone polyethylene aminopropyl ascorbyl phosphate glycine soja (soybean) protein peg-100 stearate steareth-21 dimethicone acetyl glucosamine astrocaryum murumuru seed butter trisiloxane caprylyl glycol tocopheryl acetate myristyl alcohol sodium hyaluronate hexylene glycol hydroxyethylcellulose sodium benzoate sodium citrate lecithin disodium edta phenoxyethanol yellow 5 (ci 19140) red 4 (ci 14700) [iln41936]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

de-aging

CLINIQUE
clinique smart
broad spectrum SPF 15
custom-repair moisturizer

DRY COMBINATION
NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
butyloctyl salicylate (UNII: 2EH13UN8D3)
polyester-8 (1400 MW, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)
octyldodecyl neopentanoate (UNII: X8725R883T)
docosanol (UNII: 9G1OE216XY)
butylene glycol (UNII: 3XUS85K0RA)
myristyl myristate (UNII: 4042ZC00DY)
cetyl esters wax (UNII: D072FFP9GU)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
tamarind seed (UNII: 6AHP8A7OML)
centaurium erythraea (UNII: 57X4TSH58S)
glyceryl monostearate (UNII: 230OU9XXE4)
caffeine (UNII: 3G6A5W338E)
green tea leaf (UNII: W2ZU1RY8B0)
nylon-12 (UNII: 446U8J075B)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
sucrose (UNII: C151H8M554)
biotin (UNII: 6SO6U10H04)
ergothioneine (UNII: BDZ3DQM98W)
myristyl laurate (UNII: 58U0NZN2BT)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
high density polyethylene (UNII: UG00KM4WR7)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
soybean (UNII: L7HT8F1ZOD)
peg-100 stearate (UNII: YD01N1999R)
steareth-21 (UNII: 53J3F32P58)
dimethicone (UNII: 92RU3N3Y1O)
n-acetylglucosamine (UNII: V956696549)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
trisiloxane (UNII: 9G1ZW13R0G)
caprylyl glycol (UNII: 00YIU5438U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
myristyl alcohol (UNII: V42034O9PU)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
phenoxyethanol (UNII: HIE492ZZ3T)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C red no. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-051-01	1 in 1 CARTON	10/01/2015
1		50 mL 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	10/01/2015

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-051) , REPACK(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-051) , REPACK(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-051) , REPACK(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-051)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-051)