Label: SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25- octinoxate, titanium dioxide, and zinc oxide liquid
- NDC Code(s): 10348-018-01, 10348-018-02, 10348-018-03
- Packager: SMASHBOX BEAUTY COSMETICS, INC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- 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, Octyldodecyl Neopentanoate, Butyloctyl Salicylate, Dimethicone, Butylene Glycol, Methyl Trimethicone, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethyl-siloxyethyl Dimethicone, Diethylhexyl Succinate, Laureth-4, Tocopheryl Acetate, Sodium Hyaluronate, Lecithin, Rosa Hybrid Flower Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lycium Chinense (Wolfberry) Fruit Extract, Palmitoyl Hexapeptide-14, Peat Extract, Gold, Sodium Lactate, Methicone, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Glycerin, Barium Sulfate, Magnesium Sulfate, Dimethyl Isosorbide, Maltodextrin, Triethoxycaprylylsilane, Dimethicone Crosspolymer-3, Silica, Aluminum Hydroxide, Dimethicone/PEG-10/15 Crosspolymer, Trimethylsiloxysilicate, Hexylene Glycol, Isostearic Acid, Caprylyl Glycol, Stearic Acid, Polyglyceryl-2 Triisostearate, Dipentaerythrityl Tri-Polyhydroxystearate, Dipropylene Glycol, Sodium Citrate, BHT, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Bismuth Oxychloride (CI 77163)] <ILN48115>
- Other Information
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25
octinoxate, titanium dioxide, and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 67 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NIACINAMIDE (UNII: 25X51I8RD4) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) LAURETH-4 (UNII: 6HQ855798J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) APPLE (UNII: B423VGH5S9) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) WATERMELON (UNII: 231473QB6R) GOLD (UNII: 79Y1949PYO) SODIUM LACTATE (UNII: TU7HW0W0QT) METHICONE (20 CST) (UNII: 6777U11MKT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) MALTODEXTRIN (UNII: 7CVR7L4A2D) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ISOSTEARIC ACID (UNII: X33R8U0062) CAPRYLYL GLYCOL (UNII: 00YIU5438U) STEARIC ACID (UNII: 4ELV7Z65AP) POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10348-018-01 1 in 1 CARTON 04/02/2020 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10348-018-02 7 mL in 1 TUBE; Type 0: Not a Combination Product 03/02/2022 3 NDC:10348-018-03 12 mL in 1 TUBE; Type 0: Not a Combination Product 03/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/02/2020 Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(10348-018) , label(10348-018) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(10348-018) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(10348-018) , label(10348-018) , manufacture(10348-018) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(10348-018) , label(10348-018) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(10348-018) , label(10348-018)
