VERTRA LAVA LAVA HIBISCUS SPF30- octinoxate, octocrylene, octisalate, avobenzone stick

Vertra Lava Lava Hibiscus by

Drug Labeling and Warnings

Vertra Lava Lava Hibiscus by is a Otc medication manufactured, distributed, or labeled by EAI-JR286, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.5%

Octocrylene 7%

Octisalate 5%

Avobenzone 3%

Sunscreen

INDICATIONS & USAGE

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

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 childred.  if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Reapply at least every 2 hours

Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Ricinus Communis (Castor) Seed Oil, Ozokerite, Hydrogenated Castor oil, Euphorbia Cerifera (Canelilla) Wax, Sorbitan Oleate, Cocos Nucifera(Coconut) Oil, Fragrance, 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, Armeniaca(Apricot) Kernal Oil, Ticinus Communis (Castor) Seed Oil, Santalum Album (Sandalwood) Wood Extract, Sodium Saccharin, Sorbitan Oleate, Tocopheryl Acetate.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VERTRA LAVA LAVA HIBISCUS  SPF30
octinoxate, octocrylene, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.0 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5.0 g  in 100 g
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALEURITES MOLUCCANUS WHOLE (UNII: 0592961VJA)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
PINEAPPLE (UNII: 2A88ZO081O)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCONUT OIL (UNII: Q9L0O73W7L)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERIN (UNII: PDC6A3C0OX)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MACADAMIA TERNIFOLIA WHOLE (UNII: 480C47LI24)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
ALMOND OIL (UNII: 66YXD4DKO9)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-370-02	12 in 1 KIT	04/01/2020
1	NDC: 71014-370-01	5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2019

Labeler - EAI-JR286, Inc (827896718)