PREP (AND) PRIME BB BEAUTY BALM SPF 35 BROAD SPECTRUM  SUNCREEN- octinoxate, octisalate, oxybenzone, and titanium dioxide cream 
MAKEUP ART COSMETICS

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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PREP (AND) PRIME BB BEAUTY BALM SPF 35 BROAD SPECTRUM

Drug Facts

Active IngredientsPurpose
Octinoxate 7.50%Sunscreen
Octisalate 4.00%Sunscreen
Oxybenzone 2.50%Sunscreen
Titanium Dioxide 1.10%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 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, dimethicone, butylene glycol, phenyl trimethicone, pentylene glycol, glyceryl stearate, behenyl alcohol, trioctyldodecyl citrate, polymethylsilsesquioxane, octyldodecyl stearoyl stearate, peg-40 stearate, polyglyceryl-10 pentastearate, tocopheryl acetate, sodium hyaluronate, lecithin, squalane, 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, glycerin, caffeine, cholesterol, oryzanol, trehalose, octyldodecyl neopentanoate, polyglyceryl-6 polyricinoleate, acetyl hexapeptide-8, sodium pca, sucrose, urea, silica, alumina, polyquaternium-51, sodium stearoyl lactylate, xanthan gum, ammonium acryloyldimethyltaurate/vp copolymer, polysorbate 20, sorbitan laurate, propylene glycol laurate, glycyrrhetinic acid, linoleic acid, stearic acid, isopropyl titanium triisostearate, propylene glycol stearate, disodium edta, sodium dehydroacetate, chlorphenesin, phenoxyethanol [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), zinc oxide (ci 77947)] <iln39088>

Other information

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

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MLWX

PRINCIPAL DISPLAY PANEL - 40 ML Tube Carton

M•A•C
PREP+PRIME

BB
BEAUTY BALM
SPF 35
BROAD SPECTRUM
SPF 35

40 ML/1.3 US FL OZ e

Principal Display Panel - 40 ML Tube Carton
PREP (AND) PRIME BB BEAUTY BALM SPF 35 BROAD SPECTRUM   SUNCREEN
octinoxate, octisalate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01199 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SQUALANE (UNII: GW89575KF9)  
WHEAT GERM (UNII: YR3G369F5A)  
BARLEY (UNII: 5PWM7YLI7R)  
CUCUMBER (UNII: YY7C30VXJT)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
APPLE (UNII: B423VGH5S9)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAFFEINE (UNII: 3G6A5W338E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ORYZANOL (UNII: SST9XCL51M)  
TREHALOSE (UNII: B8WCK70T7I)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SUCROSE (UNII: C151H8M554)  
UREA (UNII: 8W8T17847W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
ENOXOLONE (UNII: P540XA09DR)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0064-11 in 1 CARTON04/01/2010
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/201011/10/2020
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(40046-0064) , REPACK(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(40046-0064) , REPACK(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(40046-0064) , REPACK(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0064)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(40046-0064)

Revised: 12/2018
 
MAKEUP ART COSMETICS