67225-5130

67225-5130
SPL v2
SPL
SPL Set ID 3483e998-6122-fb84-e063-6394a90a159f
Route
TOPICAL
Published
Effective Date 2025-05-07
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
Niacinamide Stearyl Heptanoate Sodium Ascorbyl Phosphate Ferric Oxide Yellow Sodium Citrate Boron Nitride Hydrogenated Poly(c6-14 Olefin; 2 Cst) Ferrosoferric Oxide Polymethylsilsesquioxane (11 Microns) Monosodium Glutamate Ceramide Np Triisostearin Cyclomethicone 6 Aluminum Hydroxide Linoleic Acid Glycerin Triethoxycaprylylsilane Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Soybean Oil Adenosine Hyaluronic Acid Ferric Oxide Red Edetate Disodium Aloe Vera Leaf Stearic Acid P-anisic Acid Butylated Hydroxytoluene Cyclomethicone 5 Polyhydroxystearic Acid Stearate Glyceryl Caprylate C30-45 Olefin Dipropylene Glycol Cholesterol Vinylpyrrolidone/hexadecene Copolymer Betula Platyphylla Resin Candelilla Wax Squalane Tocopherol Myristoyl/palmitoyl Oxostearamide/arachamide Mea Ethylhexylglycerin Panthenol Propanediol Hydrogenated Soybean Lecithin Butylene Glycol 1,2-hexanediol C30-45 Alkyl Methicone Dimethicone Dimethicone/peg-10/15 Crosspolymer Alpha-tocopherol Acetate Pentaerythrityl Stearate Hyaluronate Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-07

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.

■ 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

■ 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 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison control center right away.

Section 50567-7

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

Section 50570-1

Do not use on damaged skin or broken skin.

Section 51727-6

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

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octinoxate 6.50%

Octocrylene 3.00%

Titanium Dioxide 5.12%

Section 60561-8

■ 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.


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)

■ 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 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison control center right away.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged skin or broken skin.

Section 51727-6 (51727-6)

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

Section 60561-8 (60561-8)

■ 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)