67225-5135-2

67225-5135-2
SPL v3
SPL
SPL Set ID 242ff053-b8c0-4f90-e063-6294a90a7bb3
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
Hydrogenated Soybean Lecithin Dipropylene Glycol Betula Platyphylla Bark Soybean Oil Aloe Vera Leaf Cyclomethicone 5 Ferric Oxide Red Polyhydroxystearic Acid Stearate 1,2-hexanediol Cholesterol Astaxanthin Boron Nitride Propanediol Stearic Acid Hyaluronate Sodium Alpha-tocopherol Acetate Myristoyl/palmitoyl Oxostearamide/arachamide Mea Squalane Glyceryl Caprylate Candelilla Wax Ferric Oxide Yellow Vinylpyrrolidone/hexadecene Copolymer Triethoxycaprylylsilane Hyaluronic Acid Niacinamide Water Monosodium Glutamate Phenyl Trimethicone Betula Platyphylla Var. Japonica Resin Aluminum Oxide P-anisic Acid C30-45 Alkyl Methicone Diethylamino Hydroxybenzoyl Hexyl Benzoate Cyclomethicone 6 Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Polymethylsilsesquioxane (11 Microns) Glycerin Ethylhexylglycerin Butylene Glycol C30-45 Olefin Haematococcus Pluvialis Dimethicone Panthenol Linoleic Acid Ferrosoferric Oxide Ceramide Np Adenosine Hydrogenated Poly(c6-14 Olefin; 2 Cst) Stearyl Heptanoate Triisostearin Aluminum Hydroxide

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: 2026-02-15T12:07:31.683653 · Updated: 2026-03-14T23:11:05.615438