Drug Facts

Composition & Product

Active Ingredients

Ensulizole (1.19 g) Octinoxate (5.25 g)

Inactive Ingredients

Water Cyclomethicone 5 Glycerin Mineral Oil Titanium Dioxide Aluminum Oxide Dimethicone Glyceryl Monostearate Peg-100 Stearate Myristyl Myristate Trolamine Cetostearyl Alcohol Stearic Acid Palmitic Acid Peg-20 Stearate Phenoxyethanol Ethylhexylglycerin Mannitol Betadex Yeast, Unspecified Sodium Succinate Anhydrous Panthenol Polyacrylamide (1500 Mw) C13-14 Isoparaffin Laureth-7 Honey Marine Collagen, Soluble Hydrolyzed Bovine Elastin (base; 1000 Mw) Sodium Pyrrolidone Carboxylate Serine Glycogen Butylene Glycol Carboxypolymethylene Polysorbate 20 Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7 .alpha.-tocopherol Acetate Sodium Polyacrylate (2500000 Mw) Polyisobutylene (1000 Mw) Allantoin Rosa Canina Fruit Oil Salicylic Acid Jasminum Officinale Flower Soy Protein Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-06-25

Medication Information

Warnings and Precautions

Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your

risk of skin cancer and early sking aging. This product has been shown only to help

prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on •damaged or broken skin

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

Stop use and ask a doctor •if rash occurs.

Indications and Usage

Uses •helps prevent sunburn

Dosage and Administration

Directions •apply liberally 15 minutes before sun exposure •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

Active ingredients Ensulizone, 1.7% Octinoxate, 7.5%

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, mineral oil,

titanium dioxide, alumina, simethicone, glyceryl stearate, PEG-100 stearate,

myristyl myristate, triethanolamine, cetearyl alcohol, stearic acid, palmitic acid, PEG-20

stearate, phenoxyehtanol, ethylhexylglycerin, mannitol, cyclodextrin, yeast extract,

disodium succinate, panthenol (pro-vitamin B-5), polyacrylamide, C13-14 isoparaffin,

laureth-7, honey extract, soluble collagen, hydrolyzed elastin, sodium PCA, serine,

glycogen, butylene glycol, carbomer, polysorbate 20, palmitoyl tripeptide-1,

palmitoyl tripeptide-7, tocopherol acetate (vitamin E), polyacrylate-13,

polyisobutene, fragrance, allantoin, rosa canina fruit oil, salicylic acid, jasminum

officinale (jasmine) flower extract, glycine soja (soybean) protein, yellow 5

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Ensulizone, 1.7%

Octinoxate, 7.5%

Structured Label Content

Indications and Usage (34067-9)