ELIXIR FINE SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream 
IXXI S.A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Elixir FINE EMULSION CREAM Sunscreen Broad Spectrum SPF 15

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:

Label

ELIXIR FINE SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70532-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70532-001-011 in 1 CARTON04/03/2016
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2016
Labeler - IXXI S.A.S. (263290505)

Revised: 4/2016
Document Id: 3035b119-79da-61a1-e054-00144ff8d46c
Set id: 2f1b6a13-647a-4c46-b5c8-52835f0c0e51
Version: 3
Effective Time: 20160411
 
IXXI S.A.S.