ACNE BB BROAD SPECTRUM SPF 40- octinoxate, octisalate, and titanium dioxide cream 
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.

----------

ACNE SOLUTIONS BB CREAM BROAD SPECTRUM SPF 40

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 2%
Titanium Dioxide 1.6%

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 • ‘methyl trimethicone • ‘alcohol‘ • ethylhexyl palmitate • ‘peg-9 polydimethylsiloxyethyl dimethicone • propanediol‘‘ • glycerin • ‘glyceryl caprylate‘ • peg-3 dimethicone‘ • dimethicone • ‘tocopheryl acetate • ‘lecithin‘ • triethoxycaprylylsilane‘ • stearyl glycyrrhetinate‘ • sorbitan sesquiisostearate‘ • sodium hyaluronate‘ • pyridoxine hcl • ‘stearic acid‘ • hesperidin methyl chalcone‘ • palmitoyl tetrapeptide-7‘ • sodium chloride‘ • aluminum hydroxide • ‘steareth-20‘ • dipeptide-2 • ‘silica • ‘sodium citrate • ‘phenoxyethanol‘ • [+/- mica • ‘iron oxides (ci 77491) • ‘iron oxides (ci 77492) • ‘iron oxides (ci 77499) • ‘titanium dioxide (ci 77891)] [iln41343]

Other information

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

acne

C
CLINIQUE

acne solutions
BB

cream
broad spectrum SPF 40

COMBINATION OILY TO OILY

1 FL.OZ.LIQ./30 ml e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
ACNE BB BROAD SPECTRUM SPF 40 
octinoxate, octisalate, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0218 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01744 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARETH-20 (UNII: L0Q8IK9E08)  
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-044-011 in 1 CARTON11/01/2014
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/01/201407/19/2021
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(49527-044) , REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(49527-044) , REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(49527-044) , REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277MANUFACTURE(49527-044) , REPACK(49527-044) , RELABEL(49527-044)
Establishment
NameAddressID/FEIBusiness Operations
JO COSMETICS691485222MANUFACTURE(49527-044)

Revised: 7/2021
 
CLINIQUE LABORATORIES LLC