HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN by

Drug Labeling and Warnings

HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ONEAND CO., LTD., Englewood Lab Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 5.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

● 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

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

STOP USE

Stop use and ask a doctor if ● rash occurs

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

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

● You may report serious side effects to: ONEAND c/o 144 Research Drive, Hampton VA 23666

DOSAGE & ADMINISTRATION

● Apply liberally and evenly 15 minutes before sun exposure

● Reapply at least every 2 hours
● Use a water-resistant sunscreen if swimming or sweating

● 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 sun
protection measures including:
● Limit time in the sun, especially from 10a.m.-2 p.m.

● Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Acrylates Copolymer, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethylhexylglycerin, Tromethamine, Fragrance (Parfum), Isohexadecane, 1,2-Hexanediol, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Tocopheryl Acetate, Polysorbate 80, Agave Tequilana Leaf Extract, Trisodium Ethylenediamine Disuccinate, Sorbitan Oleate, Glycerin, Xanthan Gum, Hyaluronic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85315-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOHEXADECANE (UNII: 918X1OUF1E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL POLYMETHACRYLATE (300000 MPA.S) (UNII: 2B25A5KAD6)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 1342 (UNII: 809Y72KV36)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
PANTHENOL (UNII: WV9CM0O67Z)
CETEARETH-20 (UNII: YRC528SWUY)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TROMETHAMINE (UNII: 023C2WHX2V)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85315-001-02	1 in 1 PACKAGE	03/14/2025
1	NDC: 85315-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/14/2025

Labeler - ONEAND CO., LTD. (694437176)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(85315-001)