CAMERA READY BB EYES BS SPF 15- octinoxate, titanium dioxide, and zinc oxide cream

CAMERA READY BB EYES BS SPF 15 by

Drug Labeling and Warnings

CAMERA READY BB EYES BS SPF 15 by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, 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 Ingredients

Octinoxate 4.10%
Titanium Dioxide 1.40%
Zinc Oxide 1.50%

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 and evenly 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 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, Cyclopentasiloxane, Dimethicone, Dimethicone Silylate, Disteardimonium Hectorite, Butylene Glycol, Phenyl Trimethicone, PEG/PPG-18/18 Dimethicone, Tocopheryl Acetate, Sodium Hyaluronate, Chamomilla Recutita (Matricaria) Flower, Caffeine, Ethylhexylglycerin, Yeast Extract\Faex\Extrait de Levure, Octyldodecyl Neopentanoate, Polyglyceryl-6 Polyricinoleate, Phytosphingosine, Acetyl Hexapeptide-8, Silica, Magnesium Sulfate, Propylene Carbonate, Triethoxycaprylylsilane, Polysilicone-11, Sorbitan Sesquioleate, Alumina, Laureth-7, Stearic Acid, Isopropyl Titanium Triisostearate, Chloroxylenol, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)] <ILN39804>

Other information

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

PRINCIPAL DISPLAY PANEL - 3.5 ml Tube Carton

smashbox
camera
ready

BB
CREAM
EYES

BROAD
SPECTRUM
SPF 15

0.12 fl. oz.
3.5 ml

INGREDIENTS AND APPEARANCE

CAMERA READY BB EYES BS SPF 15 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.04592 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01568 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0168 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Disteardimonium Hectorite (UNII: X687XDK09L)
Butylene Glycol (UNII: 3XUS85K0RA)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Chamomile (UNII: FGL3685T2X)
Caffeine (UNII: 3G6A5W338E)
Ethylhexylglycerin (UNII: 147D247K3P)
Yeast, Unspecified (UNII: 3NY3SM6B8U)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Phytosphingosine (UNII: GIN46U9Q2Q)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Propylene Carbonate (UNII: 8D08K3S51E)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Aluminum Oxide (UNII: LMI26O6933)
Laureth-7 (UNII: Z95S6G8201)
Stearic Acid (UNII: 4ELV7Z65AP)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Chloroxylenol (UNII: 0F32U78V2Q)
Phenoxyethanol (UNII: HIE492ZZ3T)
Mica (UNII: V8A1AW0880)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-011-01	1 in 1 CARTON	09/20/2013
1		3.5 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	09/20/2013

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(10348-011) , REPACK(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(10348-011) , REPACK(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(10348-011) , REPACK(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-011)