VERTRA LAVA LAVA HIBISCUS SPF30- octinoxate, octocrylene, octisalate, avobenzone stick
EAI-JR286, Inc

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.

----------

Vertra Elemental Resistance Lava Lava Hibiscus Lip Balm Moisturizer Sunscreen SPF30

Octinoxate 7.5%

Octocrylene 7%

Octisalate 5%

Avobenzone 3%

Sunscreen

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:

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.

Reapply at least every 2 hours

Children under 6 months of age: ask a doctor

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.

Protect this product from excessive heat and direct sun

LavaLips

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019	01/31/2023

Labeler - EAI-JR286, Inc (827896718)

Revised: 12/2021

Document Id: 65478f6f-a1e2-43bf-a176-3e3634c3d8dd

Set id: ec564025-35ca-49a4-8105-aa79ad0f5456

Version: 7

Effective Time: 20211210

EAI-JR286, Inc