DOUBLE WEAR ALL DAY GLOW BB MOISTURE MAKEUP BROAD SPECTRUM SPF 30- octinoxate, octisalate, titanium dioxide, and zinc oxide cream

DOUBLE WEAR ALL DAY GLOW BB MOISTURE MAKEUP BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

DOUBLE WEAR ALL DAY GLOW BB MOISTURE MAKEUP BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Octisalate 5.00%	Sunscreen
Titanium Dioxide 5.20%	Sunscreen
Zinc Oxide 3.20%	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 squalane octyldodecyl neopentanoate butylene glycol propanediol glyceryl stearate behenyl alcohol peg-40 stearate polyglyceryl-10 pentastearate sodium hyaluronate aloe barbadensis leaf water trehalose thermus thermophillus ferment tetrahexyldecyl ascorbate caffeine stearic acid sorbitol polyglyceryl-6 polyricinoleate tocopheryl acetate lecithin ammonium acryloyldimethyltaurate/vp copolymer synthetic fluorphlogopite hydrogenated lecithin sodium stearoyl lactylate linoleic acid alumina isopropyl titanium triisostearate silica tin oxide glycerin pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate xanthan gum disodium edta phenoxyethanol sodium dehydroacetate [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499) ferric ferrocyanide (ci 77510) yellow 5 lake (ci 19140) chromium oxide greens (ci 77288) chromium hydroxide green (ci 77289) carmine (ci 75470) blue 1 lake (ci 42090) bismuth oxychloride (ci 77163)] <iln40788>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

EL

ESTĒE LAUDER

Double Wear
All-Day Glow

BB

Moisture Makeup
Broad Spectrum
SPF 30

1 FL. OZ. LIQ./30ml e

INGREDIENTS AND APPEARANCE

DOUBLE WEAR ALL DAY GLOW BB MOISTURE MAKEUP BROAD SPECTRUM SPF 30 
octinoxate, octisalate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.085125 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05675 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.05902 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.03632 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-40 STEARATE (UNII: ECU18C66Q7)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TREHALOSE (UNII: B8WCK70T7I)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CAFFEINE (UNII: 3G6A5W338E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITOL (UNII: 506T60A25R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
GLYCERIN (UNII: PDC6A3C0OX)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CHROMIC OXIDE (UNII: X5Z09SU859)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
CARMINIC ACID (UNII: CID8Z8N95N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-038-01	1 in 1 CARTON	12/01/2013
1		30 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	12/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-038) , REPACK(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-038) , REPACK(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-038) , REPACK(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-038)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-038)