Label: BEYOU BROAD SPECTRUM SPF 40 SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0627-3
- Packager: Prime Enterprises Inc.
- 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 July 19, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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INACTIVE INGREDIENTS
Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Linum Usitatissimum (Linseed) Seed Oil, Niacinamide, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Physalis Angulata Extract, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Fruit Oil, Silica, Sodium Hyaluronate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
- Other Information
- Questions or Comments?
- Australian Gold Botanical Tinted Face Broad Spectrum SPF 50 (non-Kakadu)
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INGREDIENTS AND APPEARANCE
BEYOU BROAD SPECTRUM SPF 40 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0627 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 42 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 42 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) FERRIC OXIDE RED (UNII: 1K09F3G675) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ALUMINUM OXIDE (UNII: LMI26O6933) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYL LAURATE (UNII: 4CG9F9W01Q) CUCUMBER (UNII: YY7C30VXJT) LINSEED OIL (UNII: 84XB4DV00W) NIACINAMIDE (UNII: 25X51I8RD4) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Product Characteristics Color brown (Light Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0627-3 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/19/2023 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 manufacture(58443-0627) , label(58443-0627) , pack(58443-0627) , analysis(58443-0627)
