Label: ELIXIR FINE SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70532-001-01 - Packager: IXXI S.A.S.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 11, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
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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.
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INGREDIENTS AND APPEARANCE
ELIXIR FINE SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octinoxate, octocrylene creamProduct 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)
