Label: SUN SHADES SPORT PLUS- avobenzone, homosalate, octisalate, octocrylene spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 54473-212-06 - Packager: Melaleuca, Inc.
- 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 3, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- shake well before first use
- apply evenly and liberally to all exposed areas before sun exposure
- do not spray directly on face. Spray on hands to apply to face.
- use in well-ventilated area
- reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
- children under 6 months of age: ask a doctor
- STORAGE AND HANDLING
- GENERAL PRECAUTIONS
-
INACTIVE INGREDIENT
Inactive ingredients
acrylates/octylacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphates, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUN SHADES SPORT PLUS
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-212 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 4.7106 g in 177 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 25.553 g in 177 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 7.851 g in 177 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15.702 g in 177 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) BIXA ORELLANA SEED (UNII: O87354RZ5A) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) KUKUI NUT OIL (UNII: TP11QR7B8R) LEVOMENOL (UNII: 24WE03BX2T) MACADAMIA OIL (UNII: 515610SU8C) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-212-06 177 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/30/2011 Labeler - Melaleuca, Inc. (139760102)