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, Cerifera (Canelilla) Wax, Sorbitan Oleate, Cocos Nucifera() Oil, Fragrance, Phenoxyethanol, Sodium Saccharin, Tocopheryl Acetate, Ternifolia Seed Oil, Prunus Amygdalus Dulcis (Sweet ) Oil, 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 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) (AVOBENZ ONE - 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: 2A88Z O081O) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z 171K) 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: Z F94AP8MEY) WHOLE (UNII: 480C47LI24) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) PHENOXYETHANOL (UNII: HIE492Z Z 3T) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) ALMOND OIL (UNII: 66YXD4DKO9) RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) SACCHARIN SODIUM (UNII: SB8Z UX40TY) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) WATER (UNII: 059QF0KO0R)

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

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

Labeler - EAI-JR286, Inc (827896718)

Revised: 6/2021 EAI-JR286, Inc