HAWAIIAN BLEND EXTREME ZINC SPF 30- zinc oxide, titanium dioxide aerosol 
Inspec Solutions LLC.

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.

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Hawaiian Blend Extreme Zinc Broad Spectrum SPF 30 Sunscreen Spray

Active Ingredient

Zinc Oxide

Titanium Dioxide

Zinc Oxide - 19.5% ................. Sunscreen

Titanium Dioxide – 4.0%.................. Sunscreen

WARNINGS

For external use only

Do not use on damaged or broken skin

when using this product keep out of eyes-rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Apply liberally 15 minutews befor sun exposure

Reaaply:

- after 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

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 Extreme Zinc SPF 30 Spry

Hawaiian Blend Extreme Zinc SPF 30 Spray

HAWAIIAN BLEND EXTREME ZINC SPF 30 
zinc oxide, titanium dioxide aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-063-01142 g in 1 CAN; Type 0: Not a Combination Product01/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/03/2023
Labeler - Inspec Solutions LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions081030372manufacture(72667-063)

Revised: 1/2023
Document Id: f161e151-4f9b-2fbc-e053-2a95a90a5437
Set id: f15fa235-8fad-7d02-e053-2995a90a3750
Version: 2
Effective Time: 20230103
 
Inspec Solutions LLC.