85315-001 heimish rx hyaluronic acid hydrating sunscreen

85315-001 heimish rx hyaluronic acid hydrating sunscreen
SPL v4
SPL
SPL Set ID 2dc41560-f4a7-5f0b-e063-6294a90a0630
Route
topical
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (4.5 g) octocrylene (2.5 g) avobenzone (1.5 g) octisalate (2.25 g)
Inactive Ingredients
water sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) butyloctyl salicylate ethylhexylglycerin caprylyl glycol isohexadecane 1,2-hexanediol glyceryl polymethacrylate (300000 mpa.s) methyl methacrylate/glycol dimethacrylate crosspolymer propylene glycol carbomer 1342 dipropylene glycol sorbitan stearate cetearyl olivate panthenol ceteareth-20 polysorbate 60 sorbitan olivate tromethamine butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) ethylhexyl methoxycrylene

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-14

Description

Avobenzone 3.0% Homosalate 9.0% Octisalate 4.5% Octocrylene 5.0%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 5.0%

Indications and 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.

Dosage and 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

Description

Avobenzone 3.0% Homosalate 9.0% Octisalate 4.5% Octocrylene 5.0%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if ● rash occurs

Section 50567-7

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

Section 50570-1

Do not use ● on damaged or broken skin

Section 51727-6

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

Section 51945-4

Section 55105-1

Sunscreen

Section 60561-8

● 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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 5.0%

Indications and Usage (34067-9)

● 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.

Dosage and Administration (34068-7)

● 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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if ● rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use ● on damaged or broken skin

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

● 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


Advanced Ingredient Data


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