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

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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CAMERA READY BB CREAM BROAD SPECTRUM SPF 35

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
CAMERA READY BB BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0416 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.026 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.0114 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10348-015-011 in 1 CARTON01/01/201211/30/2022
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/201211/30/2022
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
PALC078364654pack(10348-015) , label(10348-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982manufacture(10348-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(10348-015) , label(10348-015)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277pack(10348-015) , label(10348-015) , manufacture(10348-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture(10348-015) , pack(10348-015) , label(10348-015)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157pack(10348-015) , label(10348-015)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774pack(10348-015) , label(10348-015)

Revised: 12/2022
 
SMASHBOX BEAUTY COSMETICS, INC