84326-124

84326-124
SPL v6
SPL
SPL Set ID 1814b5e7-5bbf-df16-e063-6294a90a96c4
Route
TOPICAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.5 g) Octisalate (2.5 g) Octocrylene (4.35 g) Homosalate (5 g)
Inactive Ingredients
Butyloctyl Salicylate Cetearyl Glucoside Adenosine Asiatic Acid .alpha.-tocopherol, Dl- Behenyl Acrylate Polymer Niacinamide Ethylene Glycol Monobenzyl Ether Glycerin Madecassic Acid Hypromellose 2208 0.45% Stearoxy Ether Polyacrylic Acid (800000 Mw) Asiaticoside Glyceryl Stearate Se Arginine Hyaluronate Sodium Water Dicaprylyl Carbonate Cetostearyl Alcohol Sorbitan Olivate Butylene Glycol Xanthan Gum Ethylhexylglycerin Centella Asiatica Triterpenoids Aloe Vera Leaf Dipropylene Glycol Panthenol Polymethylsilsesquioxane (4.5 Microns) Ethohexadiol 1,2-hexanediol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-14
Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 8.7%

Medication Information

Warnings and Precautions

For external use only

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

Directions

■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or swating.

■ 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 sun protection measures including: ■ Limit time in the sun, especially from 10a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses.

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 8.7%

Section 50565-1

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

Section 50566-9

and ask a doctor if rash occurs.

Section 50567-7

this product ■ keep out of eyes. Rinse with water to remove.

Section 50570-1

■ on damaged skin or broken skin

Section 51727-6

Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Cetearyl Glucosidde, Dipropylene Glycol, Sorbitan Olivate, Poly C10-30 Alkyl Acrylate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Tocopherol, Butylene Glycol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Glycerin, Adenosine, Ethyl Hexanediol, 1,2-Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 8.7%

Section 60561-8

■ Protect this product from excessive heat and direct sun.

Pdp Tone Blur Essence Sunscreen

Structured Label Content

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)

Directions

■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or swating.

■ 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 sun protection measures including: ■ Limit time in the sun, especially from 10a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

this product ■ keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

■ on damaged skin or broken skin

Section 51727-6 (51727-6)

Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Cetearyl Glucosidde, Dipropylene Glycol, Sorbitan Olivate, Poly C10-30 Alkyl Acrylate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Tocopherol, Butylene Glycol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Glycerin, Adenosine, Ethyl Hexanediol, 1,2-Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 8.7%

Section 60561-8 (60561-8)

■ Protect this product from excessive heat and direct sun.

Pdp Tone Blur Essence Sunscreen (PDP_Tone Blur Essence Sunscreen)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:13.631480 · Updated: 2026-03-14T23:10:29.645873