MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER- octinoxate, oxybenzone, and zinc oxide cream

MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER by

Drug Labeling and Warnings

MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER 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
Zinc Oxide 4.00%	Sunscreen
Oxybenzone 2.50%	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 of 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, butyrospermum parkii (shea butter), octyldodecyl neopentanoate, biosaccharide gum - 1, ascorbyl glucoside, sucrose, polyglyceryl-10 pentastearate, behenyl alcohol, tocopheryl acetate, sodium hyaluronate, squalane, gentiana lutea (gentian) root extract, hordeum vulgare (barley) extract\extrait d'orge, triticum vulgare (wheat) germ extract, hydrolyzed rice bran extract, algae extract, palmaria palmata extract, porphyra yezoensis (algae) extract, silk powder\serica\poudre de soie, caffeine, acetyl glucosamine, polyglyceryl-6 polyricinoleate, dipotassium glycyrrhizate, tourmaline, cholesterol, alumina, silica, polyethylene, sodium stearoyl lactylate, xanthan gum, tromethamine, caprylyl glycol, pentylene glycol, hexylene glycol, isopropyl titanium triisostearate, glyceryl stearate, peg-100 stearate, citric acid, stearic acid, fragrance (parfum), disodium edta, phenoxyethanol, sodium benzoate, chlorphenesin, mica, titanium dioxide (ci 77891) <iln41093>

Other information

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

MAC
LIGHTFUL
C

MARINE-BRIGHT FORMULA
SPF 30
MOISTURIZER
BROAD SPECTRUM
SPF 30

50 ML/1.7 US FL OZ e

INGREDIENTS AND APPEARANCE

MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER 
octinoxate, oxybenzone, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08025 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02675 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0428 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
shea butter (UNII: K49155WL9Y)
octyldodecyl neopentanoate (UNII: X8725R883T)
biosaccharide gum-1 (UNII: BB4PU4V09H)
ascorbyl glucoside (UNII: 2V52R0NHXW)
sucrose (UNII: C151H8M554)
docosanol (UNII: 9G1OE216XY)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
squalane (UNII: GW89575KF9)
gentiana lutea root (UNII: S72O3284MS)
barley (UNII: 5PWM7YLI7R)
wheat germ (UNII: YR3G369F5A)
dulse (UNII: 7832HOY4ZQ)
porphyra yezoensis (UNII: D72A570T01)
caffeine (UNII: 3G6A5W338E)
n-acetylglucosamine (UNII: V956696549)
glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)
cholesterol (UNII: 97C5T2UQ7J)
aluminum oxide (UNII: LMI26O6933)
silicon dioxide (UNII: ETJ7Z6XBU4)
high density polyethylene (UNII: UG00KM4WR7)
sodium stearoyl lactylate (UNII: IN99IT31LN)
xanthan gum (UNII: TTV12P4NEE)
tromethamine (UNII: 023C2WHX2V)
caprylyl glycol (UNII: 00YIU5438U)
pentylene glycol (UNII: 50C1307PZG)
hexylene glycol (UNII: KEH0A3F75J)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
glyceryl monostearate (UNII: 230OU9XXE4)
peg-100 stearate (UNII: YD01N1999R)
citric acid monohydrate (UNII: 2968PHW8QP)
stearic acid (UNII: 4ELV7Z65AP)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
sodium benzoate (UNII: OJ245FE5EU)
chlorphenesin (UNII: I670DAL4SZ)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0074-1	1 in 1 CARTON	02/16/2015
1		50 mL in 1 BOTTLE; 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	02/16/2015

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0074) , REPACK(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0074) , REPACK(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0074) , REPACK(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0074)