![HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]](https://medic.hrt.org//dailymed/images/86449ba8-01af-40b1-a15c-8d5fcf850600/liquid-halo-01.jpg)
| NDC | 10348-010-01 |
| Set ID | 86449ba8-01af-40b1-a15c-8d5fcf850600 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | SMASHBOX BEAUTY COSMETICS, INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least 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 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, Isododecane, Cyclopentasiloxane, Dimethicone, Butylene Glycol, Polymethyl Methacrylate, Trioctyldodecyl Citrate, Polysilicone-11, Coco-Caprylate/Caprate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Sodium Hyaluronate, Ascorbyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Quaternium-90 Bentonite, Dimethicone Silylate, Magnesium Aluminum Silicate, Alumina, Silica, Propylene Carbonate, Sodium Chloride, Caprylyl Glycol, Hexylene Glycol, Stearic Acid, Palmitic Acid, C12-16 Alcohols, Hydrogenated Lecithin, Disodium EDTA, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)] <ILN39852>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.05635 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.03335 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isododecane (UNII: A8289P68Y2) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone (UNII: 92RU3N3Y1O) Butylene Glycol (UNII: 3XUS85K0RA) Trioctyldodecyl Citrate (UNII: 35X8CT063R) Coco-Caprylate/Caprate (UNII: 8D9H4QU99H) PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Hyaluronate Sodium (UNII: YSE9PPT4TH) Ascorbyl Palmitate (UNII: QN83US2B0N) Hexyl Laurate (UNII: 4CG9F9W01Q) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Aluminum Oxide (UNII: LMI26O6933) Silicon Dioxide (UNII: ETJ7Z6XBU4) Propylene Carbonate (UNII: 8D08K3S51E) Sodium Chloride (UNII: 451W47IQ8X) Caprylyl Glycol (UNII: 00YIU5438U) Hexylene Glycol (UNII: KEH0A3F75J) Stearic Acid (UNII: 4ELV7Z65AP) Palmitic Acid (UNII: 2V16EO95H1) C12-16 Alcohols (UNII: S4827SZE3L) Edetate Disodium (UNII: 7FLD91C86K) Phenoxyethanol (UNII: HIE492ZZ3T) 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:10348-010-01 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/01/2013 Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(10348-010) , REPACK(10348-010) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(10348-010) , RELABEL(10348-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(10348-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(10348-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(10348-010) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(10348-010) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(10348-010) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(10348-010) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(10348-010) , RELABEL(10348-010)
