AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES- octinoxate, octisalate, titanium dioxide, and zinc oxide 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.

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AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 4.4%
Titanium dioxide 3.5%
Zinc oxide 2.2%

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:

Inactive ingredients

water\aqua\eau • octyldodecyl neopentanoate • butylene glycol • dimethicone • propanediol • glyceryl stearate • behenyl alcohol • peg-40 stearate • polyglyceryl-10 pentastearate • phenyl trimethicone • polymethylsilsesquioxane • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • laminaria saccharina extract • linoleic acid • oryzanol • squalane • caffeine • hydrogenated lecithin • sucrose • glycerin • polyquaternium-51 • lecithin • sodium stearoyl lactylate • polyglyceryl-6 polyricinoleate • sodium pca • isopropyl titanium triisostearate • trehalose • urea • tocopheryl acetate • sodium hyaluronate • ammonium acryloyldimethyltaurate/vp copolymer • xanthan gum • glycyrrhetinic acid • stearic acid • alumina • silica • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • chlorphenesin • sodium dehydroacetate • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica] [iln39837]

Other information

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

C

CLINIQUE

age defense

BB

cream


broad spectrum

SPF 30

ALL SKIN TYPES

1.4 FL.OZ.LIQ./40 ml e

Principal Display Panel

AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES 
octinoxate, octisalate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
WHEAT GERM (UNII: YR3G369F5A)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
ORYZANOL (UNII: SST9XCL51M)  
SQUALANE (UNII: GW89575KF9)  
CAFFEINE (UNII: 3G6A5W338E)  
SUCROSE (UNII: C151H8M554)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
TREHALOSE (UNII: B8WCK70T7I)  
UREA (UNII: 8W8T17847W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ENOXOLONE (UNII: P540XA09DR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-030-011 in 1 CARTON05/01/2013
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/01/2013
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
PALC078364654label(49527-030) , pack(49527-030)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(49527-030) , label(49527-030)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture(49527-030) , pack(49527-030) , label(49527-030)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture(49527-030) , pack(49527-030) , label(49527-030)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(49527-030) , pack(49527-030) , label(49527-030)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157pack(49527-030) , label(49527-030)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774pack(49527-030) , label(49527-030)

Revised: 4/2023
Document Id: fa587115-3fba-40b2-e053-6394a90a7796
Set id: e31dab08-08ee-4a90-b6ff-6e632c836c65
Version: 10
Effective Time: 20230427
 
CLINIQUE LABORATORIES LLC