CAMERA READY BB BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide cream

CAMERA READY BB BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

CAMERA READY BB BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, Estee Lauder Companies Inc., Len-Ron Manufacturing Division of Aramis Inc., Whitman Laboratories Ltd., Estee Lauder Cosmetics Ltd., Estee Lauder N.V., PALC, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.50%
Octisalate 4.00%
Oxybenzone 2.50%
Titanium Dioxide 1.10%

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, Dimethicone, Butylene Glycol, Phenyl Trimethicone, Pentylene Glycol, Glyceryl Stearate, Behenyl Alcohol, Trioctyldoceyl Citrate, Polymethylsilsesquioxane, Octyldodecyl Stearoyl Stearate, PEG-40 Stearate, Polyglyceryl-10 Pentastearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Triticum Vulgare (Wheat) Germ Extract, Hordeum Vulgare (Barley) Extract\Extrait D'Orge, Cucumis Sativus (Cucumber) Fruit Extract, Laminaria Saccharina Extract, Pyrus Malus (Apple) Fruit Extract, Scutellaria Baicalensis Root Extract, Polyquaternium-51, Acetyl Hexapeptide-8, Trehalose, Oryzanol, Octydodecyl Neopentanoate, Urea, Polyglyceryl-6 Polyricinoleate, Propylene Glycol Laurate, Glycyrrhetinic Acid, Tocopheryl Acetate, Sucrose, Glycerin, Sodium Stearoyl Lactylate, Caffeine, Linoleic Acid, Cholesterol, Lecithin, Squalane, Sodium PCA, Isopropyl Titanium Triisostearate, Propylene Glycol Stearate, Stearic Acid, Poly-sorbate 20, Sorbitan Laurate, Xanthan Gum, Aluminum Hydroxide, Sodium Hyaluronate, Silica, Disodium EDTA, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Dehydroacetate, Chlorphenesin, Phenoxyethanol, [+/- Titanium Dioxide (CI 77891), Zinc Oxide (CI 77947), Iron Oxides (CI 77491, CI 77492, CI 77499), Mica] <ILN37872>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

SMASHBOX
CAMERA READY
BB CREAM
BROAD SPECTRUM SPF 35

1 fl. oz. / 30 ml e

INGREDIENTS AND APPEARANCE

CAMERA READY BB BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.078 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0416 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.026 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0114 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Pentylene Glycol (UNII: 50C1307PZG)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Docosanol (UNII: 9G1OE216XY)
Trioctyldodecyl Citrate (UNII: 35X8CT063R)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Octyldodecyl Stearoyl Stearate (UNII: 3D47Q6D93C)
PEG-40 Stearate (UNII: ECU18C66Q7)
Polyglyceryl-10 Pentastearate (UNII: PMX5872701)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Wheat (UNII: 4J2I0SN84Y)
Barley (UNII: 5PWM7YLI7R)
Cucumber (UNII: YY7C30VXJT)
Apple (UNII: B423VGH5S9)
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Trehalose (UNII: B8WCK70T7I)
Gamma Oryzanol (UNII: SST9XCL51M)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Urea (UNII: 8W8T17847W)
Propylene Glycol Monolaurate (UNII: 668Z5835Z3)
Enoxolone (UNII: P540XA09DR)
Sucrose (UNII: C151H8M554)
Glycerin (UNII: PDC6A3C0OX)
Sodium stearoyl Lactylate (UNII: IN99IT31LN)
Caffeine (UNII: 3G6A5W338E)
Linoleic Acid (UNII: 9KJL21T0QJ)
Cholesterol (UNII: 97C5T2UQ7J)
SQUALANE (UNII: GW89575KF9)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Propylene Glycol Monostearate (UNII: MZM1I680W0)
Stearic Acid (UNII: 4ELV7Z65AP)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
Xanthan Gum (UNII: TTV12P4NEE)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Zinc Oxide (UNII: SOI2LOH54Z)
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: 10348-015-01	1 in 1 CARTON	01/01/2012
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	01/01/2012

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(10348-015) , REPACK(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(10348-015) , REPACK(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(10348-015) , REPACK(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-015)