HAWAIIAN SHAVED ICE LIP BALM BROAD SPECTRUM SPF 30- octinoxate, octocrylene, octisalate, avobenzone stick

Hawaiian Shaved Ice Lip Balm Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Hawaiian Shaved Ice 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

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

Directions:

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, Flavoring Agent, 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

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Hawaiian Shaved Ice Pineapple

Lip Balm

Moisturizer

Sunscreen SPF 30

Broad spectrum SPF 30

5g/ Net Wt. 18 oz

INGREDIENTS AND APPEARANCE

HAWAIIAN SHAVED ICE LIP BALM BROAD SPECTRUM SPF 30 
octinoxate, octocrylene, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PINEAPPLE (UNII: 2A88ZO081O)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
MACADAMIA OIL (UNII: 515610SU8C)
ALMOND OIL (UNII: 66YXD4DKO9)
KUKUI NUT OIL (UNII: TP11QR7B8R)
SAFFLOWER OIL (UNII: 65UEH262IS)
WATER (UNII: 059QF0KO0R)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
COCONUT OIL (UNII: Q9L0O73W7L)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-016-01	5 g in 1 CYLINDER; 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(71014-016)