83918-001_solful Face Sun Lotion

83918-001_solful Face Sun Lotion
SPL v1
SPL
SPL Set ID 1946b94b-43ae-4183-9eae-1112f0a2c951
Route
TOPICAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octocrylene (50 mg) Octisalate (40 mg) Avobenzone (30 mg)
Inactive Ingredients
Water Dipropylene Glycol Silicon Dioxide Diphenylsiloxy Phenyl Trimethicone Isohexadecane Butyloctyl Salicylate Polysorbate 80 Dimethicone/phenyl Vinyl Dimethicone Crosspolymer Ethylene Glycol Monobenzyl Ether Glyceryl Monostearate Peg-100 Stearate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Arginine Xanthan Gum Centella Asiatica Triterpenoids Butylene Glycol Ethylhexylglycerin Propanediol Bambusa Vulgaris Leaf Scleromitrion Diffusum Whole Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Lonicera Caprifolium Flower 1,2-hexanediol Hydrolyzed Glycosaminoglycans (bovine; 50000 Mw) Yeast, Unspecified Limonia Acidissima Whole Glycerin Hyaluronate Sodium Madecassic Acid Asiaticoside Asiatic Acid Caprylyl Glycol Hyaluronic Acid Ascorbyl Glucoside Sodium Ascorbyl Phosphate Magnesium Ascorbyl Phosphate Tetrahexyldecyl Ascorbate Riboflavin 5'-phosphate Sodium Anhydrous Citral Benzyl Salicylate Linalool, (+/-)- Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-27

Description

Sunscreen


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. Reapply at least every two hours

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: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Description

Sunscreen

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, Dipropylene Glycol, Silica, Diphenylsiloxy Phenyl Trimethicone, Isohexadecane, Butyloctyl Salicylate, Polysorbate 80, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Benzyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Centella Asiatica Extract, Butylene Glycol, Ethylhexylglycerin, Propanediol, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Sodium Hyaluronate Crosspolymer, Lonicera Caprifolium (Honeysuckle) Extract, 1,2-Hexanediol, Hydrolyzed Glycosaminoglycans, Yeast Extract, Limonia Acidissima Extract, Glycerin, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Madecassic Acid, Asiaticoside, Asiatic Acid, Caprylyl Glycol, Hyaluronic Acid, Ascorbyl Glucoside, Sodium Ascorbyl Phosphate, Magnesium Ascorbyl Phosphate, Tetrahexyldecyl Ascorbate, Sodium Riboflavin Phosphate, Fragrance, Citral, Benzyl Salicylate, Linalool, Limonene

Section 51945-4
Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10%, Octocrylene 5%, Octisalate 4%, Avobenzone 3%

Section 60561-8

Protect the product in the container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

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, Dipropylene Glycol, Silica, Diphenylsiloxy Phenyl Trimethicone, Isohexadecane, Butyloctyl Salicylate, Polysorbate 80, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Benzyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Centella Asiatica Extract, Butylene Glycol, Ethylhexylglycerin, Propanediol, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Sodium Hyaluronate Crosspolymer, Lonicera Caprifolium (Honeysuckle) Extract, 1,2-Hexanediol, Hydrolyzed Glycosaminoglycans, Yeast Extract, Limonia Acidissima Extract, Glycerin, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Madecassic Acid, Asiaticoside, Asiatic Acid, Caprylyl Glycol, Hyaluronic Acid, Ascorbyl Glucoside, Sodium Ascorbyl Phosphate, Magnesium Ascorbyl Phosphate, Tetrahexyldecyl Ascorbate, Sodium Riboflavin Phosphate, Fragrance, Citral, Benzyl Salicylate, Linalool, Limonene

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 10%, Octocrylene 5%, Octisalate 4%, Avobenzone 3%

Section 60561-8 (60561-8)

Protect the product in the container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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