FDA.reportPublic FDA data

Vertra Hawaiian Shaved Ice Pineapple

Manufacturer
EAI-JR286, INC
Effective date
2021-12-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:23:42

Label at a glance#

ProductVertra Hawaiian Shaved Ice Pineapple SPF30
Active ingredientOCTINOXATE, OCTOCRYLENE, Octisalate, Avobenzone
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octocrylene 7%

Octisalate 5%

Avobenzone 3%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Uses;

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

Warnings: For external use only

OTC - DO NOT USE SECTION

Do Not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out or eyes.   Rinse with water to remove.

OTC - STOP USE SECTION

Stop Use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • reapply at least every 2 hours
  • children under 6 months of age: ask a doctor

INACTIVE INGREDIENT SECTION

Ricinus Communis (Castor) Seed Oil, Ozokerite, Hydrogenated Castor oil, Euphorbia Cerifera (Candelilla) Wax, Sorbitan Oleate, Cocos Nucifera(Coconut) Oil, Flavoring Agent, Phenoxyethanol, Sodium Saccharin, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aleurites Moluccanus Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Ananas Sativus (Pineapple) Fruit Extract, Water, Mangifera Indica (Mango) Seed Butter, BHT, Glycerin, Gardenia Taitensis Flower Extract, Tocopherol, Ascorbyl Palmitate, Plumeria Rubra Flower Extract, Colocasia Antiquorum Root Extract, Hibiscus Sabdariffa Flower Extract, Potassium Sorbate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HawaiianIceLipsHawaiianIceLips

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71014-36971014-369-01, 71014-369-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
ALEURITES MOLUCCANUS WHOLE0592961VJAIACT
ALEURITES MOLUCCANA SEEDJ87WJ3E7VWIACT
PINEAPPLE2A88ZO081OIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SAFFLOWER OIL65UEH262ISIACT
COCONUT OILQ9L0O73W7LIACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT
CANDELILLA WAXWL0328HX19IACT
GLYCERINPDC6A3C0OXIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
MACADAMIA TERNIFOLIA WHOLE480C47LI24IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
ALMOND OIL66YXD4DKO9IACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
40d01cbc-e6bf-4436-afb3-e36ba5a2296fe21e77e0-3d26-4b73-aa96-6aa71a42866b2021-12-10WarningsExact identifier
spl id: 40d01cbc-e6bf-4436-afb3-e36ba5a2296f
spl set id: e21e77e0-3d26-4b73-aa96-6aa71a42866b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.