Label: UNSUN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0389-3 - 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 January 15, 2021
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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 suncreen 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, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides, 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, Triethoxycaprylylsilane, Water
- Other information
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- Unsun Mineral Tinted Face Sunscreen Lotion Broad Spectrum SPF 30
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INGREDIENTS AND APPEARANCE
UNSUN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0389 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31.5 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 POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LINSEED OIL (UNII: 84XB4DV00W) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) LAVENDER OIL (UNII: ZBP1YXW0H8) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM OXIDE (UNII: LMI26O6933) SHEA BUTTER (UNII: K49155WL9Y) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) ROSA CANINA SEED (UNII: 4503R1M9UT) STEARIC ACID (UNII: 4ELV7Z65AP) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) ALLANTOIN (UNII: 344S277G0Z) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CUCUMBER SEED (UNII: BT3S9L53JK) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYL LAURATE (UNII: 4CG9F9W01Q) Product Characteristics Color brown (Medium Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0389-3 50 mL in 1 TUBE; Type 0: Not a Combination Product 02/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/16/2021 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0389) , label(58443-0389) , analysis(58443-0389) , pack(58443-0389)