Label: BLING DAY EVERYDAY SUNSCREEN BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
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- NDC Code(s): 42361-155-01
- Packager: Dong Sung Bio Pharm. Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 28, 2019
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Warnings
For external use only. Do not use on damaged or broken skin. Discontinue use if signs of irritation or rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only.
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Directions
At the end of basic skin care regimen, apply liberally on face to cover the entire facial area and lightly go over parts where extra cover-up is needed with detailed perfection. Apply 15 minutes before sun exposure. For added protection, reapply at least every 2 hours, after swimming, towel drying or extended sun exposure. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor.
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Inactive Ingredients
Water, Cocoglycerides, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glycerin, Cetearyl Alcohol, Triethanolamine, Dimethicone, Butylene Glycol, Pentaerythrityl Distearate, Disodium Cetearyl Sulfosuccinate, Beheneth-25, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Phenoxyethanol, Magnesium Aluminum Silicate, Fragrance, Xanthan Gum, Triethoxycaprylsilane
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INGREDIENTS AND APPEARANCE
BLING DAY EVERYDAY SUNSCREEN BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42361-155 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 39 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 49 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 49 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 74 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) TROLAMINE (UNII: 9O3K93S3TK) COCO-GLYCERIDES (UNII: ISE9I7DNUG) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENOXYETHANOL (UNII: HIE492ZZ3T) BEHENETH-25 (UNII: 0G17KJ5M7P) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42361-155-01 1 in 1 CARTON 12/01/2018 1 50 g 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 12/01/2018 Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661) Registrant - Dong Sung World Wide USA, Inc. (784969219) Establishment Name Address ID/FEI Business Operations Dong Sung Bio Pharm. Co., Ltd. 687811661 label(42361-155) Establishment Name Address ID/FEI Business Operations Omar Sharif Cosmetic Co., Ltd. 689316318 manufacture(42361-155)
