Isntree Onion Newpair Sunscreen

Isntree Onion Newpair Sunscreen
SPL v4
SPL
SPL Set ID 0f072099-d57d-4dc4-e063-6394a90ab438
Route
TOPICAL
Published
Effective Date 2024-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4.5 g) Octinoxate (3.4 g) Octisalate (2.25 g) Octocrylene (2 g) Avobenzone (1.35 g)
Inactive Ingredients
Niacinamide Polymethylsilsesquioxane (4.5 Microns) C20-22 Alcohols Glycerin Cetyl Alcohol Dicaprylyl Carbonate Silicon Dioxide Titanium Dioxide Caprylyl/capryl Oligoglucoside Allantoin Panthenol Houttuynia Cordata Flowering Top C20-22 Alkyl Phosphate Water Xanthan Gum Triethoxycaprylylsilane Aluminum Oxide Tocopherol Tromethamine Pentylene Glycol Caprylyl Trisiloxane Glyceryl Monostearate Trisiloxane Onion Sorbitan Monooleate Adenosine Cocoyl Caprylocaprate Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Kaolin Medium-chain Triglycerides Ethylhexylglycerin Butylene Glycol Menadione Butyloctyl Salicylate 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-17

Description

Avobenzone 2.7 % Homosalate 9 % Octinoxate 6.8 % Octisalate 4.5 % Octocrylene 4 %

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Avobenzone 2.7 % Homosalate 9 % Octinoxate 6.8 % Octisalate 4.5 % Octocrylene 4 %

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.

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.

Active Ingredients

Avobenzone 2.7 %

Homosalate 9 %

Octinoxate 6.8 %

Octisalate 4.5 %

Octocrylene 4 %



Inactive Ingredients

Water, Butyloctyl Salicylate, Butylene Glycol, Acrylates Copolymer, Niacinamide, Polymethylsilsesquioxane, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Glycerin, Pentylene Glycol, Caprylyl Methicone, Cetyl Alcohol, Dicaprylyl Carbonate, Glyceryl Stearate, Tromethamine, Poly C10-30 Alkyl Acrylate, Silica, Coco-Caprylate/Caprate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Trisiloxane, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Allium Cepa (Onion) Bulb Extract, Ethylhexylglycerin, Kaolin, Adenosine, Polyhydroxystearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Alumina, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Tocopherol, Allantoin, Panthenol, Houttuynia Cordata Extract, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglyceryl-10 Diisostearate, Glycoproteins, Menadione, Ultramarines(CI 77007), Titanium Dioxide(CI 77891)



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.

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.

Active Ingredients (Active ingredients)

Avobenzone 2.7 %

Homosalate 9 %

Octinoxate 6.8 %

Octisalate 4.5 %

Octocrylene 4 %



Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Butylene Glycol, Acrylates Copolymer, Niacinamide, Polymethylsilsesquioxane, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Glycerin, Pentylene Glycol, Caprylyl Methicone, Cetyl Alcohol, Dicaprylyl Carbonate, Glyceryl Stearate, Tromethamine, Poly C10-30 Alkyl Acrylate, Silica, Coco-Caprylate/Caprate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Trisiloxane, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Allium Cepa (Onion) Bulb Extract, Ethylhexylglycerin, Kaolin, Adenosine, Polyhydroxystearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Alumina, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Tocopherol, Allantoin, Panthenol, Houttuynia Cordata Extract, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglyceryl-10 Diisostearate, Glycoproteins, Menadione, Ultramarines(CI 77007), Titanium Dioxide(CI 77891)



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.


Advanced Ingredient Data


Raw Label Data

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