71017-001_frudia Blueberry Hydrating Air Fit Sunscreen

71017-001_frudia Blueberry Hydrating Air Fit Sunscreen
SPL v2
SPL
SPL Set ID 8b2a1baa-e528-48d6-9cd8-c3cb55e0641b
Route
TOPICAL
Published
Effective Date 2024-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (90 mg) Homosalate (73 mg) Octisalate (47 mg) Avobenzone (27 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Niacinamide Dicaprylyl Carbonate Dipropylene Glycol Cetearyl Glucoside Behenyl Acrylate Polymer Sorbitan Olivate Polymethylsilsesquioxane (4.5 Microns) Lowbush Blueberry Ethylene Glycol Monobenzyl Ether Glyceryl Stearate Se Panthenol Carbomer Homopolymer, Unspecified Type Arginine Ganoderma Lucidum Stem .alpha.-tocopherol Acetate Glycerin Glyceryl Glucoside Edetate Disodium Ethylhexylglycerin Xanthan Gum Hypromellose 2208 0.45% Stearoxy Ether Adenosine Medium-chain Triglycerides Propanediol Hydrogenated Soybean Lecithin Hydrolyzed Glycosaminoglycans (bovine; 50000 Mw) 1,2-hexanediol Hyaluronate Sodium Tocopherol Hyaluronic Acid Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-27

Description

- 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


Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

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

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

- 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

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, Butyloctyl Salicylate, Niacinamide, Dicaprylyl Carbonate, Dipropylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Vaccinium Angustifolium (Blueberry) Fruit Extract, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Carbomer, Arginine, Ganoderma Lucidum (Mushroom) Stem Extract, Tocopheryl Acetate, Glycerin, Glyceryl Glucoside, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Caprylic/Capric Triglyceride, Propanediol, Sodium Hyaluronate Crosspolymer, Hydrogenated lecithin, Hydrolyzed Glycosaminoglycans, 1,2-Hexanediol, Sodium Hyaluronate, Tocopherol, Hydrolyzed Hyaluronic Acid, Phytosterols, Hyaluronic Acid, Fragrance

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.70%

Avobenzone 2.70%

Section 60561-8

Protect the product in this 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

Stop using and ask a doctor if rash occurs

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

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, Butyloctyl Salicylate, Niacinamide, Dicaprylyl Carbonate, Dipropylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Vaccinium Angustifolium (Blueberry) Fruit Extract, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Carbomer, Arginine, Ganoderma Lucidum (Mushroom) Stem Extract, Tocopheryl Acetate, Glycerin, Glyceryl Glucoside, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Caprylic/Capric Triglyceride, Propanediol, Sodium Hyaluronate Crosspolymer, Hydrogenated lecithin, Hydrolyzed Glycosaminoglycans, 1,2-Hexanediol, Sodium Hyaluronate, Tocopherol, Hydrolyzed Hyaluronic Acid, Phytosterols, Hyaluronic Acid, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.70%

Avobenzone 2.70%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)