ELIXIR FINE SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream

Elixir FINE Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Elixir FINE Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by IXXI S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 7.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun.

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a Water Resistant sunscreen if swimming or sweating

Sun Protection Measures. Speanding 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

Children under 6 months of age: Ask a doctor.

Other information

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

Inactive ingredients

water (aqua), coco-caprylate/caprate, cetearyl alcohol, glyceryl stearate citrate, pentylene glycol, propanediol, sodium stearoyl glutamate, butylene glycol, sodium polyacrylate, jojoba esters, glycerin, sunflower (Helianthus annuus) seed oil, sucrose laurate, sunflower (Helianthus annuus) seed cera/wax, hydrogenated starch hydrolysate, fragrance (parfum), ethylhexylglycerin, palmitoyl pine bark extract, chlorphenesin, xanthan gum, sucrose dilaurate, tocopherol, maritime pine (Pinus pinaster) bark extract, sucrose trilaurate, green wattle (Acacia decurrens) flower cera/wax, polyglycerin-3, apple (Pyrus malus) fruit extract, wild soybean (Glycine soja) oil, sodium phytate, palmitic acid, male fern (Dryopteris filis-mas) root extract, citric acid, BHT, sodium benzoate, potassium sorbate, ursolic acid, alcohol, sodium hydroxide.

Questions?

Call toll-free 1-800-322-3507

Package Labeling:

INGREDIENTS AND APPEARANCE

ELIXIR FINE SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70532-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SUCROSE LAURATE (UNII: 05Q7CD0E49)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCROSE DILAURATE (UNII: 5926LC4S7M)
TOCOPHEROL (UNII: R0ZB2556P8)
MARITIME PINE (UNII: 50JZ5Z98QY)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
PHYTATE SODIUM (UNII: 88496G1ERL)
PALMITIC ACID (UNII: 2V16EO95H1)
DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
URSOLIC ACID (UNII: P3M2575F3F)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70532-001-01	1 in 1 CARTON	04/03/2016
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2016

Labeler - IXXI S.A.S. (263290505)