LAVA LAVA LIP BALM BROAD SPECTRUM SPF 30- octinoxate, octocrylene,octisalate, avobenzone stick

Lava Lava Lip Balm Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Lava Lava Lip Balm Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by EAI-JR 286, INC, Northwest Cosmetic Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Octocrylene 7% Sunscreen

Octisalate 5% Sunscreen

Avobenzone 3% Sunscreen

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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.

DOSAGE & ADMINISTRATION

reapply at least every 2 hours

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

inactive ingredients: Ricinus Communis (Castor) Seed Oil, Ozokerite, Hydrogenated Castor Oil, Euphorbia Cerifera (candellila) Wax, Sorbitan Oleate, Cocos Nucifera (Coconut) Oil, Fragrance, Phenoxyethanol, Sodium Saccharin, Tocopheryl Acetate, Macadamia Ternifola Seed Oil, Prunus Amygdalus (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, Ricinus Communis (Castor) Seed Oil, Santalum Album (Sandalwood) wood extract, Sodium Saccharin, Sorbitan Oleate, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance Lava Lava Hibiscus

Lip Balm

Moisturizer

Sunscreen

SPF 30

5g/ Net Wt. 18 oz

INGREDIENTS AND APPEARANCE

LAVA LAVA LIP BALM BROAD SPECTRUM SPF 30 
octinoxate, octocrylene,octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
APRICOT KERNEL OIL (UNII: 54JB35T06A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALMOND OIL (UNII: 66YXD4DKO9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SANDALWOOD (UNII: 3641YW25N2)
SAFFLOWER OIL (UNII: 65UEH262IS)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
KUKUI NUT OIL (UNII: TP11QR7B8R)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PINEAPPLE (UNII: 2A88ZO081O)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
TOCOPHEROL (UNII: R0ZB2556P8)
CASTOR OIL (UNII: D5340Y2I9G)
MACADAMIA OIL (UNII: 515610SU8C)
CANDELILLA WAX (UNII: WL0328HX19)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
COCONUT OIL (UNII: Q9L0O73W7L)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-015-01	5 g in 1 JAR; Type 0: Not a Combination Product	12/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/04/2018

Labeler - EAI-JR 286, INC (827896718)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	manufacture(71014-015)