Prep (and) prime cc color correct spf30 broad spectrum cream

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active Ingredients Purpose
Octinoxate 7.40% Sunscreen
Octisalate 4.00% Sunscreen
Zinc Oxide 3.30% Sunscreen
Oxybenzone 2.50% Sunscreen
Titanium Dioxide 1.10% Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Otc - do not use section

Do not useon damaged or broken skin

Otc - when using section

When using this productkeep out of eyes. Rinse with water to remove.

Otc - stop use section

Stop use and ask a doctor ifrash occurs

Otc - keep out of reach of children section

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, hordeum vulgare (barley) extract\extrait d'orge, triticum vulgare (wheat) germ extract, laminaria saccharina extract, cucumis sativus (cucumber) fruit extract, pyrus malus (apple) fruit extract, scutellaria baicalensis root extract, caffeine, glycerin, octyldodecyl neopentanoate, polyglyceryl-6 polyricinoleate, cholesterol, oryzanol, acetyl hexapeptide-8, sodium pca, trehalose, silica, alumina, sorbitan laurate, polysorbate 20, xanthan gum, ammonium acryloyldimethyltaurate/vp copolymer, sucrose, polyquaternium-51, sodium stearoyl lactylate, triethoxycaprylylsilane, propylene glycol laurate, propylene glycol stearate, linoleic acid, stearic acid, glycyrrhetinic acid, isopropyl titanium triisostearate, urea, disodium edta, sodium dehydroacetate, phenoxyethanol, chlorphenesin [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), bismuth oxychloride (ci 77163), blue 1 lake (ci 42090), carmine (ci 75470), chromium hydroxide green (ci 77289), ferric ammonium ferrocyanide (ci 77510), ferric ferrocyanide (ci 77510), yellow 5 lake (ci 19140)] <iln40397>

Other information

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

Spl unclassified section

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ/ MR6T

Ingredients and appearance - Product information

Prep (and) prime cc color correct spf30 broad spectrum cream- Octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 40046-0069
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 0.08175 gin 100 mL
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 0.0436 gin 100 mL
Oxybenzone ( UNII: 95OOS7VE0Y)( Oxybenzone - UNII: 95OOS7VE0Y ) 0.02725 gin 100 mL
Titanium dioxide ( UNII: 15FIX9V2JP)( Titanium dioxide - UNII: 15FIX9V2JP ) 0.01199 gin 100 mL
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 0.03597 gin 100 mL

Inactive Ingredients

Ingredient Name Code
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)
Saccharina latissima ( UNII: 68CMP2MB55)
Cucumber ( UNII: YY7C30VXJT)
Apple ( UNII: B423VGH5S9)
Scutellaria baicalensis root ( UNII: 7J95K7ID2S)
Caffeine ( UNII: 3G6A5W338E)
Glycerin ( UNII: PDC6A3C0OX)
Octyldodecyl neopentanoate ( UNII: X8725R883T)
Cholesterol ( UNII: 97C5T2UQ7J)
Gamma oryzanol ( UNII: SST9XCL51M)
Acetyl hexapeptide-8 ( UNII: L4EL31FWIL)
Sodium pyrrolidone carboxylate ( UNII: 469OTG57A2)
Trehalose ( UNII: B8WCK70T7I)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Aluminum oxide ( UNII: LMI26O6933)
Sorbitan monolaurate ( UNII: 6W9PS8B71J)
Polysorbate 20 ( UNII: 7T1F30V5YH)
Xanthan gum ( UNII: TTV12P4NEE)
Ammonium acryloyldimethyltaurate/vp copolymer ( UNII: W59H9296ZG)
Sucrose ( UNII: C151H8M554)
Sodium stearoyl lactylate ( UNII: IN99IT31LN)
Triethoxycaprylylsilane ( UNII: LDC331P08E)
Propylene glycol monolaurate ( UNII: 668Z5835Z3)
Propylene glycol monostearate ( UNII: MZM1I680W0)
Linoleic acid ( UNII: 9KJL21T0QJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Enoxolone ( UNII: P540XA09DR)
Isopropyl titanium triisostearate ( UNII: 949E3KBJ1I)
Urea ( UNII: 8W8T17847W)
Edetate disodium ( UNII: 7FLD91C86K)
Sodium dehydroacetate ( UNII: 8W46YN971G)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Chlorphenesin ( UNII: I670DAL4SZ)
Mica ( UNII: V8A1AW0880)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Ferrosoferric oxide ( UNII: XM0M87F357)
Bismuth oxychloride ( UNII: 4ZR792I587)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Carminic acid ( UNII: CID8Z8N95N)
Chromium hydroxide green ( UNII: RV8FT8XF5R)
Ferric ammonium ferrocyanide ( UNII: 9R0NVI936I)
Ferric ferrocyanide ( UNII: TLE294X33A)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part352 USA

Labeler - MAKEUP ART COSMETICS( 010597206)

Establishment

Name ID/FEI Business Operations
MAKEUP ART COSMETICS 010597206 RELABEL( 40046-0069), REPACK( 40046-0069)

Principal display panel - 30 ml tube carton

MAC
PREP + PRIME
CC

COLOUR CORRECT
SPF 30
BROAD SPECTRUM
SPF 30

30 ML/1.0 US FL OZ e