Label: HAWAIIAN BLEND SENSITIVE ZINC SPF 50- zinc oxide, titanium dioxide aerosol
- NDC Code(s): 72667-062-01
- Packager: Inspec Solutions LLC.
- 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 3, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
-
INACTIVE INGREDIENT
Caprylic/Capric Triglyceride
Caprylyl Glycol
Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone
Dimethicone
Dimethicone/Methicone Copolymer
Sodium Phytate
Ethylhexylglycerin
Glycerin
Hydrogenated Polydecene
Isopropyl Myristate
Jojoba Esters
Pentylene Glycol
Polyhydroxystearic Acid
Propanediol
Silica
Sodium Chloride
Sorbitan Olivate
Stearic Acid
Synthetic Beeswax
Tetrafluoropropene
Fragrance
Water
- Hawaiian Blend Sensitive Zinc SPF 50 Spry
-
INGREDIENTS AND APPEARANCE
HAWAIIAN BLEND SENSITIVE ZINC SPF 50
zinc oxide, titanium dioxide aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-062 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.5 g in 100 g Inactive Ingredients Ingredient Name Strength PENTYLENE GLYCOL (UNII: 50C1307PZG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) (UNII: KB7T6C99UP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) SORBITAN OLIVATE (UNII: MDL271E3GR) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) GLYCERIN (UNII: PDC6A3C0OX) 2,3,5,6-TETRAFLUOROPHENOL (UNII: TNA118I5TG) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PHYTATE SODIUM (UNII: 88496G1ERL) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72667-062-01 142 g in 1 CAN; Type 0: Not a Combination Product 01/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/03/2023 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions 081030372 manufacture(72667-062)