67225-5013-2

67225-5013-2
SPL v4
SPL
SPL Set ID 247ef1f8-ad12-4f80-e063-6394a90a3e3c
Route
TOPICAL
Published
Effective Date 2022-09-07
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
Vinylpyrrolidone/hexadecene Copolymer Stearic Acid Glyceryl Caprylate Glycerin Adenosine Polyhydroxystearic Acid Stearate Hyaluronic Acid Boron Nitride Triethoxycaprylylsilane Aluminum Oxide Cholesterol Astaxanthin Hydrogenated Soybean Lecithin Ferrosoferric Oxide Stearyl Heptanoate Myristoyl/palmitoyl Oxostearamide/arachamide Mea Linoleic Acid Aloe Vera Leaf Betula Platyphylla Var. Japonica Resin Butylene Glycol Squalane Propanediol Dimethicone Cyclomethicone 5 Polymethylsilsesquioxane (11 Microns) P-anisic Acid Candelilla Wax Triisostearin 1,2-hexanediol Dipropylene Glycol Niacinamide Monosodium Glutamate Betula Platyphylla Bark Ferric Oxide Red Aluminum Hydroxide C30-45 Alkyl Methicone C30-45 Olefin Panthenol Ceramide Np Water Hyaluronate Sodium Ferric Oxide Yellow Phenyl Trimethicone Diethylamino Hydroxybenzoyl Hexyl Benzoate Hydrogenated Poly(c6-14 Olefin; 2 Cst) Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Haematococcus Pluvialis Soybean Oil Ethylhexylglycerin Alpha-tocopherol Acetate Cyclomethicone 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-07

Description

Octinoxate 6.50 % Octocrylene 3.00 % Titanium Dioxide 5.12 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.50 % Octocrylene 3.00 % Titanium Dioxide 5.12 %

Uses

Helps prevent sunburn.

Section 51945-4

Warnings

For external use only.

Directions

■ 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.

Do Not Use On

damaged skin or broken skin.

Other Information

■ 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.

Active Ingredients

Octinoxate 6.50 %

Octocrylene 3.00 %

Titanium Dioxide 5.12 %

Inactive Ingredients

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))

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Helps prevent sunburn.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

Directions

■ 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.

Do Not Use On (Do not use on)

damaged skin or broken skin.

Other Information (Other information)

■ 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.

Active Ingredients (Active ingredients)

Octinoxate 6.50 %

Octocrylene 3.00 %

Titanium Dioxide 5.12 %

Inactive Ingredients (Inactive ingredients)

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))

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)