67225-5015

67225-5015
SPL v3
SPL
SPL Set ID 242b7d0e-82d8-793c-e063-6294a90a4aa3
Route
TOPICAL
Published
Effective Date 2024-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.42 g) Octinoxate (0.91 g) Titanium Dioxide (0.7168 g)
Inactive Ingredients
Vinylpyrrolidone/hexadecene Copolymer Triethoxycaprylylsilane Hyaluronic Acid Hydrogenated Soybean Lecithin Myristoyl/palmitoyl Oxostearamide/arachamide Mea Aloe Vera Leaf Cyclomethicone 5 Triisostearin Dipropylene Glycol Niacinamide P-anisic Acid Stearyl Heptanoate Propanediol Ethylhexylglycerin Glycerin Betula Platyphylla Bark Water Ferric Oxide Yellow Stearic Acid Monosodium Glutamate Hyaluronate Sodium Phenyl Trimethicone Hydrogenated Poly(c6-14 Olefin; 2 Cst) Linoleic Acid Ferrosoferric Oxide Betula Platyphylla Var. Japonica Resin Butylene Glycol Squalane Polymethylsilsesquioxane (11 Microns) C30-45 Olefin Ceramide Np Haematococcus Pluvialis C30-45 Alkyl Methicone Aluminum Oxide 1,2-hexanediol Aluminum Hydroxide Panthenol Diethylamino Hydroxybenzoyl Hexyl Benzoate Alpha-tocopherol Acetate Cyclomethicone 6 Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Cholesterol Astaxanthin Dimethicone Candelilla Wax Ferric Oxide Red Soybean Oil Polyhydroxystearic Acid Stearate Glyceryl Caprylate Adenosine Boron Nitride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-11
Description

Octinoxate 6.50 % Octocrylene 3.00 % Titanium Dioxide 5.12 %

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

■ Apply the product on your skin with the included applicator by rubbing the product with the applicator and gently patting it on your skin.

■ 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.

Description

Octinoxate 6.50 % Octocrylene 3.00 % Titanium Dioxide 5.12 %

Section 44425-7

■ Protect the product in this container from excessive heat and avoid storing it under direct sun.

■ Do not crush or drop product.

■ Handle with care.

■ 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.

Section 50565-1

If swallowed, get medical help or contact a poison control center right away.

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 50570-1

damaged skin or broken skin.

Section 51727-6

Betula Platyphylla Japonica Bark Extract, Betula Platyphylla Japonica Juice, Dipropylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Phenyl Trimethicone, Niacinamide, Hydrogenated Poly(C6-14 Olefin), Euphorbia Cerifera (Candelilla) Wax, Dimethicone, Cyclopentasiloxane, Butylene Glycol, Squalane, Aloe Barbadensis Leaf Extract, Triisostearin, 1,2-Hexanediol, Cyclohexasiloxane, Polymethylsilsesquioxane, Propanediol, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Glutamate, VP/Hexadecene Copolymer, Aluminum Hydroxide, C30-45 Alkyl Methicone, p-Anisic Acid, Dimethicone/PEG-10/15 Crosspolymer, Stearic Acid, C30-45 Olefin, Glyceryl Caprylate, Glycerin, Triethoxycaprylylsilane, Alumina, Tocopheryl Acetate, Panthenol, Ceramide NP, Stearyl Heptanoate, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Adenosine, Cholesterol, Water, Sodium Hyaluronate, Polyhydroxystearic Acid, Hydrolyzed Hyaluronic Acid, Lactobacillus Ferment Lysate, Haematococcus Pluvialis Extract, Linoleic Acid, Boron Nitride, Astaxanthin, Aphanothece Sacrum Polysaccharide, Glycine Soja (Soybean) Oil, Lecithin, Ethylhexylglycerin, sh-Polypeptide-60, Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Benzyl Salicylate, Linalool, +/- may contain (Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499))

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octinoxate 6.50 %

Octocrylene 3.00 %

Titanium Dioxide 5.12 %

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

■ Apply the product on your skin with the included applicator by rubbing the product with the applicator and gently patting it on your skin.

■ 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.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

■ Protect the product in this container from excessive heat and avoid storing it under direct sun.

■ Do not crush or drop product.

■ Handle with care.

■ 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.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away.

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

damaged skin or broken skin.

Section 51727-6 (51727-6)

Betula Platyphylla Japonica Bark Extract, Betula Platyphylla Japonica Juice, Dipropylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Phenyl Trimethicone, Niacinamide, Hydrogenated Poly(C6-14 Olefin), Euphorbia Cerifera (Candelilla) Wax, Dimethicone, Cyclopentasiloxane, Butylene Glycol, Squalane, Aloe Barbadensis Leaf Extract, Triisostearin, 1,2-Hexanediol, Cyclohexasiloxane, Polymethylsilsesquioxane, Propanediol, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Glutamate, VP/Hexadecene Copolymer, Aluminum Hydroxide, C30-45 Alkyl Methicone, p-Anisic Acid, Dimethicone/PEG-10/15 Crosspolymer, Stearic Acid, C30-45 Olefin, Glyceryl Caprylate, Glycerin, Triethoxycaprylylsilane, Alumina, Tocopheryl Acetate, Panthenol, Ceramide NP, Stearyl Heptanoate, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Adenosine, Cholesterol, Water, Sodium Hyaluronate, Polyhydroxystearic Acid, Hydrolyzed Hyaluronic Acid, Lactobacillus Ferment Lysate, Haematococcus Pluvialis Extract, Linoleic Acid, Boron Nitride, Astaxanthin, Aphanothece Sacrum Polysaccharide, Glycine Soja (Soybean) Oil, Lecithin, Ethylhexylglycerin, sh-Polypeptide-60, Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Benzyl Salicylate, Linalool, +/- may contain (Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499))

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octinoxate 6.50 %

Octocrylene 3.00 %

Titanium Dioxide 5.12 %

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.680140 · Updated: 2026-03-14T23:11:05.615438