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

AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES by

Drug Labeling and Warnings

AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES 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

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:

• 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 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.084375 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0495 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.039375 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.02475 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-030-01	1 in 1 CARTON	05/01/2013
1		40 mL in 1 TUBE; 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	05/01/2013

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-030) , REPACK(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-030) , REPACK(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-030) , REPACK(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-030)