CAMERA READY BB WATER BROAD SPECTRUM SPF 30- octinoxate, titanium dioxide, and zinc oxide lotion 
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 WATER BROAD SPECTRUM SPF 30

Drug Facts

Active Ingredients

Octinoxate 5%
Titanium Dioxide 3.1%
Zinc Oxide 2.1%

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, Methyl Trimethicone, Phenyl Trimethicone, Silica, Butyloctyl Salicylate, Dimethicone, Neopentyl Glycol Diheptanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone Silylate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Ethylhexyl Palmitate, Glycerin, Polysilicone-11, Tocopheryl Acetate, Sodium Hyaluronate, Lecithin, Citrullus Vulgaris (Watermelon) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Protein, PEG-10 Dimethicone, Sodium PCA, Methicone, Triethyl Citrate, Thermus Thermophillus Ferment, Laureth-7, Trimethylsiloxysilicate, Silica Dimethyl Silylate, Magnesium Aluminum Silicate, Polymethylsilsesquioxane, Triethoxycaprylylsilane, Dextrin, Disteardimonium Hectorite, Xanthan Gum, Sodium Chloride, Dimethicone/PEG-10/15 Crosspolymer, Sodium Lactate, Caprylyl Glycol, Hexylene Glycol, Zinc Stearate, Litchi Chinensis Seed Extract, Polyglutamic Acid, Laminaria Saccharina Extract, Disodium EDTA, Sodium Dehydroacetate, Phenoxyethanol, Potassium Sorbate, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)] <ILN41387>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

smashbox
camera
ready

BB
WATER

BROAD SPECTRUM
SPF 30

BROAD SPECTRUM SPF 30
1 fl. oz. / 30 ml e

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
CAMERA READY BB WATER BROAD SPECTRUM SPF 30 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.056 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.03472 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.02352 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
WATERMELON (UNII: 231473QB6R)  
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
APPLE (UNII: B423VGH5S9)  
SOY PROTEIN (UNII: R44IWB3RN5)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
LAURETH-7 (UNII: Z95S6G8201)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ZINC STEARATE (UNII: H92E6QA4FV)  
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10348-012-011 in 1 CARTON04/06/2015
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/06/201511/16/2020
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(10348-012) , REPACK(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(10348-012) , REPACK(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(10348-012) , REPACK(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-012)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(10348-012)

Revised: 11/2020
 
SMASHBOX BEAUTY COSMETICS, INC