Protective Day

Protective Day
SPL v4
SPL
SPL Set ID 62978f1d-5e77-47a4-984c-112451bcd903
Route
TOPICAL
Published
Effective Date 2022-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octinoxate (75 mg) Octocrylene (20 mg)
Inactive Ingredients
Butylene Glycol Tribehenin Peg-20 Esters Water Isopropyl Lauroyl Sarcosinate Pentylene Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isodecyl Neopentanoate Cyclomethicone 5 Ocimum Basilicum Root Watermelon Black Olive Vicia Lens Fruit Apple Soybean Eleuthero Asian Ginseng American Ginseng Shea Butter Ceramide Np Rosa Multiflora Fruit Potassium Hydroxide Sodium Lactate Salicornia Europaea Whole Starch, Corn Sodium Pyrrolidone Carboxylate Diisopropyl Sebacate Lauryl Lactate Medium-chain Triglycerides Glycerin Silicon Dioxide Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-08-20 Until 2026-03-31
Description

Avobenzone 3% Homosalate 10% Octinoxate 7.5% Octocrylene 2%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octinoxate 7.5% Octocrylene 2%

uses

• 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

• on damaged or broken skin.

Drug Facts

Directions:

• Apply 2-3 pumps of product to face and neck

• Apply generously and evenly 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• . 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.–2:00 p.m.• wear long-sleeved shirts, pants, hats, and sunglasses Sun Protection Measures

• Children under 6 months of age: Ask a doctor

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 2%

Package Labeling: 

other Information

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

Inactive Ingredients:

Water, Butylene Glycol, Tribehenin PEG-20 Esters, Isopropyl Lauroyl Sarcosinate, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isodecyl Neopentanoate, Cyclopentasiloxane, Ocimum Basilicum Hairy Root Culture Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Olea Europaea (Olive) Fruit Extract*, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Seed Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Panax Ginseng Root Extract, Panax Quinquefolius Root Extract, Butyrospermum Parkii (Shea) Butter, Ceramide NP, Rosa Multiflora Fruit Extract, Potassium Hydroxide, Sodium Lactate, Salicornia Herbacea Extract, Hydrolyzed Corn Starch, Sodium PCA, Diisopropyl Sebacate, Lauryl Lactate, Caprylic/Capric Triglyceride, Glycerin, Silica, Citric Acid, Fragrance.

(continued) Drug Facts

Questions Or Comments?

Call toll free 1-800-950-9595

When Using This Product

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

Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 

• rash occurs.

Structured Label Content

Purpose

Sunscreen

uses (Uses)

• 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.

Drug Facts

Directions:

• Apply 2-3 pumps of product to face and neck

• Apply generously and evenly 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• . 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.–2:00 p.m.• wear long-sleeved shirts, pants, hats, and sunglasses Sun Protection Measures

• Children under 6 months of age: Ask a doctor

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 2%

Package Labeling: 

other Information (Other Information)

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

Inactive Ingredients:

Water, Butylene Glycol, Tribehenin PEG-20 Esters, Isopropyl Lauroyl Sarcosinate, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isodecyl Neopentanoate, Cyclopentasiloxane, Ocimum Basilicum Hairy Root Culture Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Olea Europaea (Olive) Fruit Extract*, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Seed Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Panax Ginseng Root Extract, Panax Quinquefolius Root Extract, Butyrospermum Parkii (Shea) Butter, Ceramide NP, Rosa Multiflora Fruit Extract, Potassium Hydroxide, Sodium Lactate, Salicornia Herbacea Extract, Hydrolyzed Corn Starch, Sodium PCA, Diisopropyl Sebacate, Lauryl Lactate, Caprylic/Capric Triglyceride, Glycerin, Silica, Citric Acid, Fragrance.

(continued) Drug Facts

Questions Or Comments? (Questions or Comments?)

Call toll free 1-800-950-9595

When Using This Product (When using this product)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

• rash occurs.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:25.701690 · Updated: 2026-03-14T23:14:11.403934