Isntree Hyaluronic Acid Natural Sun Cream

Isntree Hyaluronic Acid Natural Sun Cream
SPL v2
SPL
SPL Set ID 2a86be75-c0f3-a8a1-e063-6294a90a0448
Route
TOPICAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.9 g)
Inactive Ingredients
Isododecane Disiloxane Caprylyl Methicone Panthenol C15-19 Alkane Polymethylsilsesquioxane (4.5 Microns) Caprylyl Glycol Glyceryl Caprylate Sodium Hyaluronate Inositol 1,2-hexanediol Tocopherol Triethoxycaprylylsilane Dipropylene Glycol Sodium Citrate Water Betaine Propylheptyl Caprylate Butyloctyl Salicylate Butylene Glycol Sodium Chloride Cetyl Diglyceryl Tris(trimethylsiloxy)silylethyl Dimethicone (3500 Mm2/s) Triethylhexanoin Glycerin Polyglyceryl-2 Dipolyhydroxystearate Disteardimonium Hectorite Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-31

Description

Zinc Oxide 17.8 %

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Zinc Oxide 17.8 %

Uses

• helps prevent sunburn • higher SPF gives more sunburn protection

• 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

Section 51945-4

Warnings

For external use only.

Directions

■ apply liberally 15 minutes before sun exposure.

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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

■ children under 6 months of age: Ask a doctor

■ reapply at least every 2 hours.

■ use a water-resistant sunscreen if swimming or sweating.

Do Not Use

• on damaged skin or broken skin.

Active Ingredient

Zinc Oxide 17.8 %

Other Information

■ protect the product from excessive heat and

direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and

using sunscreens may reduce the risks of skin aging, skin cancer, and other

harmful effects of the sun.

Inactive Ingredients

Water, Butyloctyl Salicylate, Propylheptyl Caprylate, Butylene Glycol, Isododecane, C15-19 Alkane, Disiloxane, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Sodium Chloride, Triethylhexanoin, Glycerin, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Triethoxycaprylylsilane, Polymethylsilsesquioxane, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-2 Dipolyhydroxystearate, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Caprylyl Glycol, Glyceryl Caprylate, Dipropylene Glycol, Sodium Hyaluronate, Tocopherol, Sodium Citrate, Betaine, Inositol, Panthenol

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

•rash or irritation develops and lasts.

Keep Out of Reach of Children

If swallowed, get medical help or contact

a Poison Control Center right away.


Structured Label Content

Uses

• helps prevent sunburn • higher SPF gives more sunburn protection

• 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

Section 51945-4 (51945-4)

Purpose

sunscreen

Warnings

For external use only.

Directions

■ apply liberally 15 minutes before sun exposure.

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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

■ children under 6 months of age: Ask a doctor

■ reapply at least every 2 hours.

■ use a water-resistant sunscreen if swimming or sweating.

Do Not Use (Do not use)

• on damaged skin or broken skin.

Active Ingredient (Active ingredient)

Zinc Oxide 17.8 %

Other Information (Other information)

■ protect the product from excessive heat and

direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and

using sunscreens may reduce the risks of skin aging, skin cancer, and other

harmful effects of the sun.

Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Propylheptyl Caprylate, Butylene Glycol, Isododecane, C15-19 Alkane, Disiloxane, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Sodium Chloride, Triethylhexanoin, Glycerin, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Triethoxycaprylylsilane, Polymethylsilsesquioxane, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-2 Dipolyhydroxystearate, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Caprylyl Glycol, Glyceryl Caprylate, Dipropylene Glycol, Sodium Hyaluronate, Tocopherol, Sodium Citrate, Betaine, Inositol, Panthenol

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•rash or irritation develops and lasts.

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.


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