Label: UNSUN BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0305-3 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
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 20, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure
Reapply
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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. to 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
Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Glycerin, Hexyl Laurate, Lavandula Angustifolia (Lavender) Oil, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane,Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Water
- Other Information
- Questions or comments?
- Unsun SPF 15 Mineral Body Lotion
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INGREDIENTS AND APPEARANCE
UNSUN BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18.375 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 31.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHYSALIS ANGULATA (UNII: W4TKW9D5GG) CUCUMBER SEED (UNII: BT3S9L53JK) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ROSA CANINA SEED (UNII: 4503R1M9UT) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) LINSEED OIL (UNII: 84XB4DV00W) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) LAVENDER OIL (UNII: ZBP1YXW0H8) ALLANTOIN (UNII: 344S277G0Z) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) STEARIC ACID (UNII: 4ELV7Z65AP) SHEA BUTTER (UNII: K49155WL9Y) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0305-3 87 mL in 1 TUBE; Type 0: Not a Combination Product 03/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/28/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 manufacture(58443-0305) , label(58443-0305) , analysis(58443-0305) , pack(58443-0305)
