![MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MAKEUP ART COSMETICS]](https://medic.hrt.org//dailymed/images/c26ef380-1309-4a41-862f-eb319d38673d/mac-01.jpg)
| NDC | 40046-0063-1 |
| Set ID | c26ef380-1309-4a41-862f-eb319d38673d |
| 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
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two hours
- use a water resistant sunscreen if swimming or sweating
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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
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inactive ingredients
water\aqua\eau, butyloctyl salicylate, methyl trimethicone, neopentyl glycol diheptanoate, aleurites moluccana (kukui) seed oil, lauryl peg-9 polydimethylsiloxyethyl dimethicone, peg-100 stearate, butylene glycol, glyceryl stearate, dipentaerythrityl tri-polyhydroxystearate, sodium hyaluronate, lavandula angustifolia (lavender) flower water, laminaria ochroleuca extract, laminaria digitata extract, algae extract, caffeine, ethylhexylglycerin, caprylic/capric triglyceride, sorbitol, methyldihydrojasmonate, ergothioneine, dehydroxanthan gum, vp/eicosene copolymer, saccharide isomerate, ammonium acryloyldimethyltaurate/vp copolymer, potassium cetyl phosphate, caprylyl glycol, citric acid, stearic acid, cetyl alcohol, linalool, limonene, disodium edta, phenoxyethanol, sodium dehydroacetate, mica <iln40739>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Carton
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INGREDIENTS AND APPEARANCE
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0309 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.0515 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0515 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.0278 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0309 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) KUKUI NUT OIL (UNII: TP11QR7B8R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAFFEINE (UNII: 3G6A5W338E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITOL (UNII: 506T60A25R) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) ERGOTHIONEINE (UNII: BDZ3DQM98W) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) SACCHARIDE ISOMERATE (UNII: W8K377W98I) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL ALCOHOL (UNII: 936JST6JCN) LINALOOL, (+/-)- (UNII: D81QY6I88E) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0063-1 1 in 1 CARTON 02/02/2012 1 30 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 02/02/2012 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(40046-0063) , REPACK(40046-0063) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0063) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(40046-0063) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0063) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0063) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(40046-0063) , REPACK(40046-0063) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(40046-0063) , REPACK(40046-0063) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0063) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(40046-0063)
