BEYOU BROAD SPECTRUM SPF 40 SUNSCREEN- titanium dioxide, zinc oxide lotion 
Prime Enterprises Inc.

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.

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BeYou Dialy Moisturizer Mineral Sunscreen Broad Spectrum SPF 40

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 4%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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?

Call Toll free 1-87742396877

Australian Gold Botanical Tinted Face Broad Spectrum SPF 50 (non-Kakadu)

Principle Display Label

BEYOU  BROAD SPECTRUM SPF 40 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0627
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (Light Tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0627-350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/19/2023
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028manufacture(58443-0627) , label(58443-0627) , pack(58443-0627) , analysis(58443-0627)

Revised: 7/2023
Document Id: 00d88975-4cf9-898b-e063-6394a90adf85
Set id: 00d85a52-ea70-3ae1-e063-6394a90a1902
Version: 1
Effective Time: 20230719
 
Prime Enterprises Inc.