Label: PEARLIXIME ILLUMINATING PERFECTING SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70532-005-01 - Packager: IXXI S.A.S.
- Category: HUMAN OTC DRUG LABEL
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 4, 2016
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- 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), glycerin, cetearyl alcohol, glyceryl stearate citrate, pentylene glycol, butylene glycol, rice (Oryza sative) powder, fragrance (parfum), sodium polyacrylate, sodium stearoyl glutamate, palmitoyl pine bark extract, kiwi (Actinidia chinensis) fruit water, ethylhexylglycerin, sucrose laurate, hydrogenated starch hydrosylate, chlorphenesin, xanthan gum, alcohol, sucrose dilaurate, tocopherol, shrubby sophota (sophora flavescens) root extract, wild soybean (glycine soja) oil, sodium phytate, sucrose trilaurate, palmitic acid, hydrolyzed algae extract, bog bean (Menyanthes trifoliata) leaf extract, BHT, ascorbic acid, citric acid, sodium hydroxide.
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INGREDIENTS AND APPEARANCE
PEARLIXIME ILLUMINATING PERFECTING SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octinoxate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70532-005 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 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) RICE BRAN (UNII: R60QEP13IC) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) KIWI FRUIT OIL (UNII: 66086CWP3Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SUCROSE LAURATE (UNII: 05Q7CD0E49) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) ALCOHOL (UNII: 3K9958V90M) SUCROSE DILAURATE (UNII: 5926LC4S7M) TOCOPHEROL (UNII: R0ZB2556P8) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) PALMITIC ACID (UNII: 2V16EO95H1) MENYANTHES TRIFOLIATA (UNII: 7H0QTZ446K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70532-005-01 1 in 1 CARTON 04/03/2016 1 50 mL in 1 TUBE; 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)
