LIGHTFUL C SPF 30 WITH RADIANCE BOOSTER BROAD SPECTRUM SPF 30- octinoxate, octisalate, oxybenzone, and titanium dioxide cream

LIGHTFUL C SPF 30 WITH RADIANCE BOOSTER BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

LIGHTFUL C SPF 30 WITH RADIANCE BOOSTER BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Octisalate 4.00%	Sunscreen
Oxybenzone 2.50%	Sunscreen
Titanium Dioxide 1.10%	Sunscreen

Use

helps prevent sunburn

Smooth evenly all over the face or to the desired areas after moisturizer with finger tips, sponge, or brush.

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, propanediol, glyceryl stearate, phenyl trimethicone, behenyl alcohol, trioctyldodecyl citrate, polymethylsilsesquioxane, ascorbyl glucoside, peg-40 stearate, polyglyceryl-10 pentastearate, octyldodecyl stearoyl stearate, tocopheryl acetate, tocopheryl linoleate/oleate, sodium hyaluronate, lecithin, squalane, hordeum vulgare (barley) extract\extrait d'orge, triticum vulgare (wheat) germ extract, gentiana lutea (gentian) root extract, glycyrrhiza glabra (licorice) root extract, cucumis sativus (cucumber) fruit extract, laminaria saccharina extract, pyrus malus (apple) fruit extract, scutellaria baicalensis root extract, hydrolyzed rice bran extract, caffeine, glycerin, ergothioneine, octyldodecyl neopentanoate, polyglyceryl-6 polyricinoleate, cholesterol, sodium pca, oryzanol, trehalose, acetyl hexapeptide-8, bisabolol, dimethoxytolyl propylresorcinol, alumina, silica, urea, polyquaternium-51, sucrose, xanthan gum, ammonium acryloyldimethyltaurate/vp copolymer, sodium stearoyl lactylate, glycyrrhetinic acid, stearic acid, linoleic acid, isopropyl titanium triisostearate, disodium edta, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tetrahexyldecyl ascorbate, sodium dehydroacetate, phenoxyethanol, chlorphenesin [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), zinc oxide (ci 77947)] <iln40872>

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 / MTX 4

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Carton

MAC
LIGHTFUL
c

TINTED CREAM
SPF 30
WITH RADIANCE BOOSTER
BROAD SPECTRUM
SPF 30

40 ML/ 1.3 US FL OZ e

INGREDIENTS AND APPEARANCE

LIGHTFUL C SPF 30 WITH RADIANCE BOOSTER BROAD SPECTRUM SPF 30 
octinoxate, octisalate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01199 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
propanediol (UNII: 5965N8W85T)
glyceryl monostearate (UNII: 230OU9XXE4)
phenyl trimethicone (UNII: DR0K5NOJ4R)
docosanol (UNII: 9G1OE216XY)
trioctyldodecyl citrate (UNII: 35X8CT063R)
ascorbyl glucoside (UNII: 2V52R0NHXW)
peg-40 stearate (UNII: ECU18C66Q7)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
squalane (UNII: GW89575KF9)
barley (UNII: 5PWM7YLI7R)
wheat germ (UNII: YR3G369F5A)
gentiana lutea root (UNII: S72O3284MS)
glycyrrhiza glabra (UNII: 2788Z9758H)
cucumber (UNII: YY7C30VXJT)
saccharina latissima (UNII: 68CMP2MB55)
apple (UNII: B423VGH5S9)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
caffeine (UNII: 3G6A5W338E)
glycerin (UNII: PDC6A3C0OX)
ergothioneine (UNII: BDZ3DQM98W)
octyldodecyl neopentanoate (UNII: X8725R883T)
cholesterol (UNII: 97C5T2UQ7J)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
gamma oryzanol (UNII: SST9XCL51M)
trehalose (UNII: B8WCK70T7I)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
levomenol (UNII: 24WE03BX2T)
aluminum oxide (UNII: LMI26O6933)
silicon dioxide (UNII: ETJ7Z6XBU4)
urea (UNII: 8W8T17847W)
sucrose (UNII: C151H8M554)
xanthan gum (UNII: TTV12P4NEE)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
sodium stearoyl lactylate (UNII: IN99IT31LN)
enoxolone (UNII: P540XA09DR)
stearic acid (UNII: 4ELV7Z65AP)
linoleic acid (UNII: 9KJL21T0QJ)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
edetate disodium (UNII: 7FLD91C86K)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
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)
zinc oxide (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0070-1	1 in 1 CARTON	12/01/2013
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2013

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0070) , REPACK(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0070) , REPACK(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0070) , REPACK(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0070)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0070)