BYOMA MOISTURIZING SUNSCREEN SPF 30- avobenzone, homosalate, octisalate gel

Byoma Moisturizing Sunscreen SPF 30 by

Drug Labeling and Warnings

Byoma Moisturizing Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by BYOMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3%,

Homosalate 10%,

Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed wtih other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.

Warnings

For external use only

When using this product

keep out of eyes. Rinse with water to remove.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• Use a water resistant sunscreen if swiming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months of age: ask a doctor.
• 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 sunprotection measures including
• Limit time in the sun, especially from 10am-2pm
• Wear long sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Beta-Glucan, Sodium Hyaluronate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Ceramide NP, Cholesterol, Phytosphingosine, Caprylyl Glycol, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, Stearic Acid, Oleic Acid, Dibutyl Lauroyl Glutamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Lecithin, Eugenia Caryophyllus (Clove) Bud Extract, Hydroxyacetophenone, Lactic Acid, Lecithin, Octyldodecanol, 1,2-Hexanediol, Panthenol, Poly C10-30 Alkyl Acrylate, Pullulan, Sclerotium Gum, Sodium Polyacryloyldimethyl Taurate, Solidago Virgaurea Extract, Tocopherol, Xanthan Gum.

Questions or Comments?

contact hello@byoma.com

Product Packaging

INGREDIENTS AND APPEARANCE

BYOMA MOISTURIZING SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84821-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
SOLIDAGO VIRGAUREA WHOLE (UNII: F45YHM06JE)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CERAMIDE NP (UNII: 4370DF050B)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
PANTHENOL (UNII: WV9CM0O67Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
DIMETHICONE (UNII: 92RU3N3Y1O)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
PULLULAN (UNII: 8ZQ0AYU1TT)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
STEARIC ACID (UNII: 4ELV7Z65AP)
OLEIC ACID (UNII: 2UMI9U37CP)
EUGENIA CARYOPHYLLUS (CLOVE) BUD EXTRACT (UNII: K48IKT5321)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LACTIC ACID (UNII: 33X04XA5AT)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
OCTYLDODECANOL (UNII: 461N1O614Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
TOCOPHEROL (UNII: R0ZB2556P8)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84821-001-50	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2023

Labeler - BYOMA LIMITED (228554984)