Label: SUN SHADES SPORT SPORT PLUS- avobenzone, homosalate, octisalate, and octocrylene spray
- NDC Code(s): 54473-163-06
- 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 January 11, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- GENERAL PRECAUTIONS
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
acrylates/octacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphate, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN SHADES SPORT SPORT PLUS
avobenzone, homosalate, octisalate, and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-163 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 23.553 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:54473-163-06 177 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2009 Labeler - Melaleuca, Inc. (139760102) Registrant - Melaleuca, Inc. (079711683)
