Your browser does not support JavaScript! EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, AND OCTISALATE) CREAM [CLINIQUE LABORATORIES INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

Out of scope

EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15 (avobenzone, homosalate, and octisalate) cream
[CLINIQUE LABORATORIES INC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 3.0%
Octisalate 5.0%

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 • tricaprylyl citrate • butylene glycol • butyrospermum parkii (shea butter) • yeast extract\faex\extrait de levure • cetearyl alcohol • polymethyl methacrylate • glycerin • sucrose • polyester-8 • saccharomyces cerevisiae extract • peg-100 stearate • dimethicone • glyceryl stearate • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • saccharomyces lysate extract • scutellaria baicalensis root extract • morus bombycis (mulberry) root extract • betula alba (birch) bark extract • oryza sativa (rice) bran extract • chamomilla recutita (matricaria) extract • helianthus annuus (sunflower) seedcake • caffeine • polyglutamic acid • salicylic acid • propylene glycol dicaprate • sodium rna • dipotassium glycyrrhizate • acetyl glucosamine • phospholipids • arginine • sodium hyaluronate • squalane • cetearyl glucoside • ethylhexylglycerin • isohexadecane • tocopheryl acetate • polysorbate 80 • caprylyl glycol • magnesium ascorbyl phosphate • acrylamide/sodium acryloyldimethyltaurate copolymer • xanthan gum • disodium edta • phenoxyethanol [iln38633]

Other information

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

© CLINIQUE LABORATORIES, DIST. N.Y., N.Y. 10022

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

CLINIQUE

even better

dark spot correcting
hand cream
broad spectrum
SPF 15

ALL SKIN TYPES

2.5 FL.OZ.LIQ./75 ml e

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM   SPF 15
avobenzone, homosalate, and octisalate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49527-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.03 g  in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE0.03 g  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
tricaprylyl citrate 
butylene glycol 
shea butter 
yeast 
cetostearyl alcohol 
glycerin 
sucrose 
saccharomyces cerevisiae 
peg-100 stearate 
dimethicone 
glyceryl monostearate 
barley 
cucumber 
saccharomyces lysate 
scutellaria baicalensis root 
morus australis root 
betula pubescens bark 
rice bran 
matricaria recutita 
helianthus annuus seedcake 
caffeine 
salicylic acid 
propylene glycol dicaprate 
glycyrrhizinate dipotassium 
n-acetylglucosamine 
arginine 
hyaluronate sodium 
squalane 
cetearyl glucoside 
ethylhexylglycerin 
isohexadecane 
.alpha.-tocopherol acetate 
polysorbate 80 
caprylyl glycol 
magnesium ascorbyl phosphate 
xanthan gum 
edetate disodium 
phenoxyethanol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-013-011 in 1 CARTON
175 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2011
Labeler - CLINIQUE LABORATORIES INC (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(49527-013), REPACK(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(49527-013), RELABEL(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-013)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(49527-013), RELABEL(49527-013)

Revised: 10/2012
 
CLINIQUE LABORATORIES INC

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services