PREP PLUS PRIME BB BEAUTY BALM COMPACT  BROAD SPECTRUM SPF 30- octinoxate, octisalate, titanium dioxide, and zinc oxide 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+PRIME BB BEAUTY BALM COMPACT BROAD SPECTRUM SPF 30

Drug Facts

Active IngredientsPurpose
Octinoxate 7.50%Sunscreen
Octisalate 5.00%Sunscreen
Titanium Dioxide 9.80%Sunscreen
Zinc Oxide 6.30%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 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-sleezed shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

inactive ingredients

octyldodecyl neopentanoate, neopentyl glycol diheptanoate, polyethylene, butyloctyl salicylate, hdi/trimethylol hexyllactone crosspolymer, beeswax\cera alba\cire d'abeille, phenyl trimethicone, c12-15 alkyl benzoate, silica, polybutene, alumina, tocopherol, tocopheryl acetate, glycyrrhiza glabra (licorice) root extract, astrocaryum murumuru seed butter, santalum album seed extract, glycine soja (soybean) oil, elaeis guineensis (palm) oil, euphorbia cerifera (candelilla) wax\candelilla cera\cire de candelilla, hydrogenated cottonseed oil, sodium hyaluronate, squalene, cetyl dimethicone, phytosterols, tocotrienols, ethylhexyl palmitate, triethyl citrate, caprylyl methicone, bis-diglyceryl polyacyladipate-2, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-6 polyricinoleate, caprylyl glycol, butylene glycol, nylon-12, disteardimonium hectorite, triethoxycaprylylsilane, vp/eicosene copolymer, synthetic beeswax, allyl methacrylates crosspolymer, silica dimethyl silylate, lauric acid, isopropyl titanium triisostearate, dipentaerythrityl tri-polyhydroxystearate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499)] <iln39107>

Other information

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

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 8g Jar Carton

M•A•C
PREP+PRIME

BB
BEAUTY BALM
COMPACT SPF 30
BROAD SPECTRUM SPF 30

NET WT. / 8g / 0.28 US OZ e

Principal Display Panel - 8g Jar Carton
PREP PLUS PRIME BB BEAUTY BALM COMPACT   BROAD SPECTRUM SPF 30
octinoxate, octisalate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
SANTALUM ALBUM SEED (UNII: 7RZT0U509Y)  
SOYBEAN OIL (UNII: 241ATL177A)  
PALM OIL (UNII: 5QUO05548Z)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SQUALENE (UNII: 7QWM220FJH)  
TOCOTRIENOLS (UNII: KP2MW85SSQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NYLON-12 (UNII: 446U8J075B)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
LAURIC ACID (UNII: 1160N9NU9U)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
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:40046-0062-11 in 1 CARTON04/01/2010
18 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/201011/20/2020
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(40046-0062) , REPACK(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(40046-0062) , REPACK(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(40046-0062) , REPACK(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(40046-0062)

Revised: 12/2018
 
MAKEUP ART COSMETICS