67225-5331-2

67225-5331-2
SPL v3
SPL
SPL Set ID 247afcae-855e-3f69-e063-6394a90a4231
Route
TOPICAL
Published
Effective Date 2024-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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: 2026-02-15T12:07:32.259836 · Updated: 2026-03-14T23:11:05.615438