CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY- avobenzone and octisalate cream

CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY by

Drug Labeling and Warnings

CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. 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 butyloctyl salicylate glycerin polyester-8 polysorbate 60 cetyl alcohol butylene glycol sorbitan stearate dimethicone tridecyl stearate peg-100 stearate saccharomyces ferment filtrate sodium hyaluronate camellia sinensis leaf extract astrocaryum murumuru seed butter tridecyl trimellitate dipentaerythrityl hexacaprylate/hexacaprate algae extract plankton extract laminaria saccharina extract tamarindus indica seed extract sigesbeckia orientalis (st. paul's wort) extract acetyl glucosamine whey protein\lactis protein\protéine du petit-lait glycine soja (soybean) protein centaurium erythraea (centaury) extract cetyl palmitate polyethylene acrylates/c10-30 alkyl acrylate crosspolymer acetyl hexapeptide-8 biotin aminopropyl ascorbyl phosphate sorbitan palmitate sorbitan olivate ethylhexylglycerin caffeine tocopheryl acetate ethylene/va copolymer sodium polyacrylate trehalose ergothioneine lecithin hydroxyethylcellulose sodium benzoate sodium hydroxide pentylene glycol disodium edta phenoxyethanol chlorphenesin yellow 5 (ci 19140) red 4 (ci 14700) [iln41849]

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

COMBINATION OILY TO OILY

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-050
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)
butyloctyl salicylate (UNII: 2EH13UN8D3)
glycerin (UNII: PDC6A3C0OX)
polysorbate 60 (UNII: CAL22UVI4M)
cetyl alcohol (UNII: 936JST6JCN)
butylene glycol (UNII: 3XUS85K0RA)
sorbitan monostearate (UNII: NVZ4I0H58X)
dimethicone (UNII: 92RU3N3Y1O)
tridecyl stearate (UNII: A8OE252M6L)
peg-100 stearate (UNII: YD01N1999R)
hyaluronate sodium (UNII: YSE9PPT4TH)
green tea leaf (UNII: W2ZU1RY8B0)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
tridecyl trimellitate (UNII: FY36J270ES)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
saccharina latissima (UNII: 68CMP2MB55)
tamarind seed (UNII: 6AHP8A7OML)
n-acetylglucosamine (UNII: V956696549)
soy protein (UNII: R44IWB3RN5)
centaurium erythraea (UNII: 57X4TSH58S)
cetyl palmitate (UNII: 5ZA2S6B08X)
high density polyethylene (UNII: UG00KM4WR7)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
biotin (UNII: 6SO6U10H04)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
sorbitan monopalmitate (UNII: 77K6Z421KU)
sorbitan olivate (UNII: MDL271E3GR)
ethylhexylglycerin (UNII: 147D247K3P)
caffeine (UNII: 3G6A5W338E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
trehalose (UNII: B8WCK70T7I)
ergothioneine (UNII: BDZ3DQM98W)
sodium benzoate (UNII: OJ245FE5EU)
sodium hydroxide (UNII: 55X04QC32I)
pentylene glycol (UNII: 50C1307PZG)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)
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: 49527-050-01	1 in 1 CARTON	12/01/2015
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	12/01/2015

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-050) , REPACK(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-050) , REPACK(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-050) , REPACK(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-050)