67225-5032

67225-5032
SPL v5
SPL
SPL Set ID 11f37a57-47ce-4175-e063-6394a90a92ee
Route
TOPICAL
Published
Effective Date 2024-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.91 g) Titanium Dioxide (0.7168 g) Octocrylene (0.42 g)
Inactive Ingredients
P-anisic Acid Ceramide Np Hyaluronate Sodium Ethylhexylglycerin Adenosine Butylated Hydroxytoluene Pentaerythrityl Stearate Monosodium Glutamate Ferrosoferric Oxide Stearic Acid Triisostearin Stearyl Heptanoate 1,2-hexanediol Phenyl Trimethicone Cyclomethicone 5 Polymethylsilsesquioxane (11 Microns) Hydrogenated Poly(c6-14 Olefin; 2 Cst) Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-16

Description

Octinoxate 6.50% Titanium Dioxide 5.12% Octocrylene 3.00%


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 10a.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% Titanium Dioxide 5.12% Octocrylene 3.00%

Section 50565-1

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

Section 50566-9

and ask a doctor ■ rash occurs.

Section 50567-7

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

Section 50570-1

■ damaged skin or broken skin

Section 51727-6

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

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octinoxate 6.50%

Titanium Dioxide 5.12%

Octocrylene 3.00%

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 10a.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)

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

Section 50566-9 (50566-9)

and ask a doctor ■ rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

■ damaged skin or broken skin

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octinoxate 6.50%

Titanium Dioxide 5.12%

Octocrylene 3.00%

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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