NDC | 40046-0079-1 |
Set ID | 81b7ba72-1dcc-4f50-86d4-cd6a5be287cc |
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 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, peg-30 dipolyhydroxystearate, dimethicone, ethylhexyl palmitate, caprylic/capric triglyceride, neopentyl glycol diethylhexanoate, triethylhexanoin, butylene glycol, glycerin, octydodecyl neopentanoate, squalane, silica, tocopherol, tocopheryl acetate, sodium hyaluronate, lysine, butyrospermum parkii (shea butter), haberlea rhodopensis leaf extract, tamarindus indica seed extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, yeast extract\faex\extrait de levure, phytantriol, octyldodecyl pca, sodium pca, trehalose, magnesium chloride, sodium chloride, potassium chloride, zinc chloride, simethicone, synthetic fluorphlogopite, disteardimonium hectorite, polyglyceryl-3 beeswax, triethoxycaprylylsilane, dimethicone crosspolymer-3, tin oxide, urea, triacetin, polyquaternium-51, caprylyl glycol, hexylene glycol, hydrogenated lecithin, disodium edta, phenoxyethanol, sodium dehydroacetate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499)] <iln39648>
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
-
INGREDIENTS AND APPEARANCE
MAC MINERALIZE MOISTURE SPF 15 BROAD SPECTRUM FOUNDATION
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0835 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.0217 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) SQUALANE (UNII: GW89575KF9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LYSINE (UNII: K3Z4F929H6) SHEA BUTTER (UNII: K49155WL9Y) BEET (UNII: N487KM8COK) PHYTANTRIOL (UNII: 8LVI07A72W) SODIUM (UNII: 9NEZ333N27) PIDOLIC ACID (UNII: SZB83O1W42) TREHALOSE (UNII: B8WCK70T7I) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM CHLORIDE (UNII: 451W47IQ8X) POTASSIUM CHLORIDE (UNII: 660YQ98I10) ZINC CHLORIDE (UNII: 86Q357L16B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STANNIC OXIDE (UNII: KM7N50LOS6) UREA (UNII: 8W8T17847W) TRIACETIN (UNII: XHX3C3X673) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0079-1 1 in 1 CARTON 07/02/2012 1 30 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 07/02/2012 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(40046-0079) , REPACK(40046-0079) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0079) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(40046-0079) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0079) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0079) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(40046-0079) , REPACK(40046-0079) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(40046-0079) , REPACK(40046-0079) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0079) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(40046-0079)