HAWAIIAN BLEND EXTREME ZINC SPF 30- zinc oxide, titanium dioxide aerosol

Hawaiian Blend Extreme Zinc SPF 30 by

Drug Labeling and Warnings

Hawaiian Blend Extreme Zinc SPF 30 by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC., Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide

Titanium Dioxide

PURPOSE

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

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

WARNINGS

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

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Apply liberally 15 minutews befor sun exposure

Reaaply:

- after 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

INDICATIONS & USAGE

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

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 Extreme Zinc SPF 30 Spry

INGREDIENTS AND APPEARANCE

HAWAIIAN BLEND EXTREME ZINC SPF 30 
zinc oxide, titanium dioxide aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-063
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: 72667-063-01	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(72667-063)