NDC | 40046-0074-1 |
Set ID | ed4ca733-dbff-4ee7-b6c5-1ccad7a0717b |
Category | HUMAN OTC DRUG LABEL |
Packager | MAKEUP ART COSMETICS |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
-
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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER
octinoxate, oxybenzone, and zinc oxide creamProduct 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)