Label: EX-GLOW-SION SPF-20- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69863-103-11, 69863-103-12, 69863-103-51 - Packager: HATCHBEAUTY PRODUCTS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 21, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Shake well before use
- Apply generously to face 15 minutes before sun exposure.
- Children under 6 months of age: ask a doctor.
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early 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.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating; immediately after towel drying. -
Inacitve Ingredients
Water/Aqua/Eau, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Propylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Isononyl Isononanoate, Silica, Butylene Glycol, Trimethylsiloxysilicate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Alcohol Denat., Quaternium-18 Hectorite, Glycerin, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Flower/Leaf/Stem Extract, Jasminum Officinale (Jasmine) Flower Extract, Amaranthus Caudatus Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ceramide 3, Niacinamide, Bisabolol, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Sodium Chloride, Xanthan Gum, Sucrose Palmitate, Maltodextrin, Perfluorodecalin, Pyridoxine HCl, Calcium Pantothenate, Synthetic Fluorphlogopite, Polysorbate 20, Triethoxycaprylylsilane, Bis-Phenylpropyl Dimethicone, Sodium Starch Octenylsuccinate, Ethylhexylglycerin,
Ethylbisiminomethylguaiacol Manganese Chloride, Phenoxyethanol. May Contain: Iron Oxides (CI 77491/77492/77499). - OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EX-GLOW-SION SPF-20
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69863-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 3.7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) SILICON (UNII: Z4152N8IUI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ARGAN OIL (UNII: 4V59G5UW9X) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALCOHOL (UNII: 3K9958V90M) QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX) GLYCERIN (UNII: PDC6A3C0OX) PEACH JUICE (UNII: K37IH01KN1) VITIS VINIFERA WHOLE (UNII: 22E66I250J) OENOTHERA BIENNIS (UNII: 76UI55V071) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M) JOJOBA OIL (UNII: 724GKU717M) CERAMIDE 3 (UNII: 4370DF050B) NIACINAMIDE (UNII: 25X51I8RD4) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SODIUM CHLORIDE (UNII: 451W47IQ8X) XANTHAN GUM (UNII: TTV12P4NEE) SUCROSE PALMITATE (UNII: 3OSQ643ZK5) MALTODEXTRIN (UNII: 7CVR7L4A2D) PERFLUNAFENE (UNII: 54A06VV62N) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) POLYSORBATE 20 (UNII: 7T1F30V5YH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69863-103-51 1 in 1 BOX 1 NDC:69863-103-11 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:69863-103-12 7 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 final part352 12/16/2015 Labeler - HATCHBEAUTY PRODUCTS LLC (044612361) Registrant - HATCHBEAUTY PRODUCTS LLC (044612361)
