83888-001_mania Holic Sunscreen Pack

83888-001_mania Holic Sunscreen Pack
SPL v4
SPL
SPL Set ID b95a460c-1f7b-4193-b305-466e073af640
Route
TOPICAL
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (90 mg) Homosalate (72 mg) Octisalate (48 mg) Avobenzone (28 mg)
Inactive Ingredients
Water Powdered Cellulose Butyloctyl Salicylate Silicon Dioxide Dipropylene Glycol Niacinamide Diphenylsiloxy Phenyl Trimethicone Ethylene Glycol Monobenzyl Ether Polysorbate 80 Glyceryl Monostearate Polymethylsilsesquioxane (4.5 Microns) Peg-100 Stearate Dimethicone/phenyl Vinyl Dimethicone Crosspolymer Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Arginine Behenyl Acrylate Polymer Xanthan Gum Ethylhexylglycerin Adenosine 1,2-hexanediol Hyaluronate Sodium Sodium Acetylated Hyaluronate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-19

Description

Apply liberally 15 minutes before sun exposure. avoid excessive rubbing during application, as it may result in clumping or uneven texture, for makeup application, allow it to completely dry for one minute, best results when applied over base makeup. 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 of 15 of higher and other sun protection measures including: Limited time in the sun, especially from 10 am to 2 pm, Wear long-sleeve shirts, pants, hats, and sunglasses. reapply at least every 2 hours, use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor


Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin

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

Stop using and ask a doctor if rash occurs.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure. avoid excessive rubbing during application, as it may result in clumping or uneven texture, for makeup application, allow it to completely dry for one minute, best results when applied over base makeup.

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 of 15 of higher and other sun protection measures including: Limited time in the sun, especially from 10 am to 2 pm, Wear long-sleeve shirts, pants, hats, and sunglasses. reapply at least every 2 hours, use a water-resistant sunscreen if swimming or sweating.

Children under 6 months of age: Ask a doctor

Description

Apply liberally 15 minutes before sun exposure. avoid excessive rubbing during application, as it may result in clumping or uneven texture, for makeup application, allow it to completely dry for one minute, best results when applied over base makeup. 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 of 15 of higher and other sun protection measures including: Limited time in the sun, especially from 10 am to 2 pm, Wear long-sleeve shirts, pants, hats, and sunglasses. reapply at least every 2 hours, use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, Cellulose, Butyloctyl Salicylate, Silica, Dipropylene Glycol, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Benzyl Glycol, Polysorbate 80, Glyceryl Stearate, Polymethylsilsesquioxane, PEG-100 Stearate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Poly C10-30 Alkyl Acrylate, Xanthan Gum, Ethylhexylglycerin, Adenosine, 1,2-Hexanediol, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octocrylene 9%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 2.8%

Section 60561-8

Store away from direct sunlight.

Keep the lid closed when not in use.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. avoid excessive rubbing during application, as it may result in clumping or uneven texture, for makeup application, allow it to completely dry for one minute, best results when applied over base makeup.

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 of 15 of higher and other sun protection measures including: Limited time in the sun, especially from 10 am to 2 pm, Wear long-sleeve shirts, pants, hats, and sunglasses. reapply at least every 2 hours, use a water-resistant sunscreen if swimming or sweating.

Children under 6 months of age: Ask a doctor

Warnings and Precautions (34071-1)

For external use only

Do not use on damaged or broken skin

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

Stop using and ask a doctor if rash occurs.

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Cellulose, Butyloctyl Salicylate, Silica, Dipropylene Glycol, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Benzyl Glycol, Polysorbate 80, Glyceryl Stearate, Polymethylsilsesquioxane, PEG-100 Stearate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Poly C10-30 Alkyl Acrylate, Xanthan Gum, Ethylhexylglycerin, Adenosine, 1,2-Hexanediol, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octocrylene 9%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 2.8%

Section 60561-8 (60561-8)

Store away from direct sunlight.

Keep the lid closed when not in use.


Advanced Ingredient Data


Raw Label Data

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