67225-5025

67225-5025
SPL v2
SPL
SPL Set ID 3483e4fa-883b-fb9c-e063-6394a90adcc4
Route
TOPICAL
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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 50566-9

Stop use and ask a doctor if rash occurs.

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

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

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