drug facts

drug facts
SPL v1
SPL
SPL Set ID 142f99de-176e-ad11-e063-6394a90a935b
Route
topical
Published
Effective Date 2024-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (9.5 g) avobenzone (2.9 g) octisalate (4.9 g)
Inactive Ingredients
opuntia ficus-indica leaf green tea leaf diisobutyl succinate isobornyl acrylate acetyl zingerone stearic acid medium-chain triglycerides ethyl ferulate rubus idaeus seed tetrahexyldecyl ascorbate panthenol potassium sorbate glycyrrhiza glabra levomenol althaea officinalis root methylpropanediol ectoine denatonium benzoate haematococcus pluvialis vanilla bean rice bran caprylyl glycol palmitic acid sodium benzoate water ethylhexyl methoxycrylene dibutyl maleate mauritia flexuosa fruit oil meadowfoam seed oil glycerin brassica rapa subsp. rapa seed tert-butyl alcohol alcohol butyloctyl salicylate polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) polyglyceryl-3 diisostearate phenylpropanol phosphatidylcholine translocator abcb4 mannitol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-21

Description

Active ingredients Avobenzone 2.9% Octisalate 4.9% Octocrylene 9.5%


Medication Information

Warnings and Precautions

Warnings: Flammable. Keep away from fire or flame. • For external use only

Active Ingredient

Active ingredients

Avobenzone 2.9%

Octisalate 4.9%

Octocrylene 9.5%

Indications and Usage

Uses • 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

Directions • shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • avoid contact with eyes • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor • 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

Description

Active ingredients Avobenzone 2.9% Octisalate 4.9% Octocrylene 9.5%

Section 50565-1

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if • rash occurs

Section 50567-7

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

Section 50570-1

Do not use • on damaged or broken skin

Section 51727-6

Inactive ingredients: Alcohol, Diisooctyl Succinate, Butyloctyl Salicylate, Aqua/water/Eau, Ethylhexyl Methoxycrylene, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Alcohol Denat., Acetyl Zingerone, Caprylie/Capric Triglyceride, Ethyl Ferulate, Polyester-8, Mauritia Flexuosa Fruit Oil, Limnanthes Alba Seed Oil, Glycerin, Brassica Campestris Seed Oil, Rubus Idaeus Seed Oil, T-Butyl Alcohol, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra Root Extract, Polyglyceryl-3 Diisostearate, Opuntia Ficus-Indica Leaf Cell Extract, Camellia Sinensis Leaf Extract, Bisabolol, Phosphatidylcholine, Althaea Officinalis Root Extract, Oryza Sativa Bran Extract, Mannitol, Methylpropanediol, Ectoin, Caprylyl Glycol, Denatonium Benzoate, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 60561-8

Other information • protect the product in this container from excessive heat and direct sun.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings: Flammable. Keep away from fire or flame. • For external use only

Active Ingredient (55106-9)

Active ingredients

Avobenzone 2.9%

Octisalate 4.9%

Octocrylene 9.5%

Indications and Usage (34067-9)

Uses • 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)

Directions • shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • avoid contact with eyes • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor • 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

Section 50565-1 (50565-1)

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use • on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients: Alcohol, Diisooctyl Succinate, Butyloctyl Salicylate, Aqua/water/Eau, Ethylhexyl Methoxycrylene, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Alcohol Denat., Acetyl Zingerone, Caprylie/Capric Triglyceride, Ethyl Ferulate, Polyester-8, Mauritia Flexuosa Fruit Oil, Limnanthes Alba Seed Oil, Glycerin, Brassica Campestris Seed Oil, Rubus Idaeus Seed Oil, T-Butyl Alcohol, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra Root Extract, Polyglyceryl-3 Diisostearate, Opuntia Ficus-Indica Leaf Cell Extract, Camellia Sinensis Leaf Extract, Bisabolol, Phosphatidylcholine, Althaea Officinalis Root Extract, Oryza Sativa Bran Extract, Mannitol, Methylpropanediol, Ectoin, Caprylyl Glycol, Denatonium Benzoate, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 60561-8 (60561-8)

Other information • protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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