BEYOU BROAD SPECTRUM SPF 40 SUNSCREEN- titanium dioxide, zinc oxide lotion

BeYou by

Drug Labeling and Warnings

BeYou by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 4%

Purpose

Sunscreen

Uses

• helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• 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

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

• Protect this product from excessive heat and direct sun
• May stain some fabrics or surfaces

Questions or Comments?

Call Toll free 1-87742396877

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

INGREDIENTS AND APPEARANCE

BEYOU  BROAD SPECTRUM SPF 40 SUNSCREEN
titanium dioxide, zinc oxide lotion

Product 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)