DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (.96 g) Octisalate (2.41 g) Octocrylene

Inactive Ingredients

Water Cyclomethicone 5 Glycerin Glyceryl Monostearate Peg-100 Stearate Medium-chain Triglycerides Yellow Wax Jojoba Oil Myristyl Myristate Cetostearyl Alcohol Stearic Acid Squalane Polyglyceryl-10 Pentastearate Docosanol Sodium Stearoyl Lactylate Phenoxyethanol Ethylhexylglycerin Diethylhexyl 2,6-naphthalate Sodium Acrylate Polyisobutylene (1300 Mw) Polysorbate 20 Butylene Glycol Carbomer 940 Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7 Steareth-2 .alpha.-tocopherol Acetate Trolamine Lecithin, Soybean Soy Isoflavones Polysorbate 80 Xanthan Gum Titanium Dioxide Trimethoxycaprylylsilane Allantoin Edetate Disodium Anhydrous Dipalmitoyl Hydroxyproline Soy Protein Vitamin A Palmitate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-05-10

Medication Information

Warnings and Precautions

Warnings

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 use and ask a doctor •if rash occurs

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 •apply liberally 15 minutes before sun

exposure •reapply at least every 2 hours •use water

resistant sunscrenn if swimming or sweating •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 SpectrumSPF

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% Octisalate, 5% Octocrylene, 5%

Section 44425-7

Other information •protect the product in this

container from excessive heat and direct sun.

Section 50565-1

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients Water, Cyclopentasiloxane, Glycerin, Glyceryl Stearate,

PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil,

Myristyl Myristate, Cetearyl Alcohol, Stearic Acid, Squalane, Polyglyceryl-10 Pentastearate,

Behenyl Alcohol, Sodium Steroyl Lactylate, Phenoxyethanol, Ethylhexylglycerin,

Diethylhexyl 2,6-Naphthalate, Polyacrylate-13, Polyisobutene, Polysorbate 20,

Butylene Glycol, Carbomer, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7,

Steareth-2, Tocopheryl Acetate (Vitamin E), Triethanolamine, Fragrance,

Lecithin, Soy Isoflavones, Polysorbate 80, Xanthan Gum, Titanium Dioxide,

Trimethoxycaprylylsilane, Allantoin, Disodium EDTA, Dipalmitoyl Hydroxyproline,

Glycine Soja (Soybean) Protein, Retinyl Palmitate (Vitamin A).

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients:

Avobenzone, 2%

Octisalate, 5%

Octocrylene, 5%

Structured Label Content

Indications and Usage (34067-9)