VERTRA REEF SAFE LIP BALM SPF 15- zinc oxide stick

Vertra Reef Safe Lip Balm SPF 15 by

Drug Labeling and Warnings

Vertra Reef Safe Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Eai-jr 286, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Zinc Oxide 10.5% Sunscreen

PURPOSE

Uses:

• helps Prevent Sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an 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

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only

DOSAGE & ADMINISTRATION

Directions

• Reapply at least every 2 hours.
• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Natural Flavors, Polyhydroxystearic Acid, Butyrospermum Pakii (Shea) Butter, Rubus Ideaus (Red Raspberry) Seed Oil, Theobroma Cocoa (Cocoa) Seed Butter, Tocopherol, Simmondsia Chinensis (Jojoba) Oil, Calophyllum Inophyllum (Tamanu) Seed Oil.

PRINCIPAL DISPLAY PANEL

Vertra Premium Sunscare Reef Safe

Lip Balm Moisturizer Sunscreen

SPF 15

Broad Spectrum SPF 15

Water Resistant ( 80 Min)

NET WT .15oz (4.25g)

INGREDIENTS AND APPEARANCE

VERTRA REEF SAFE LIP BALM SPF 15 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TAMANU OIL (UNII: JT3LVK84A1)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
RASPBERRY SEED OIL (UNII: 9S8867952A)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WHITE WAX (UNII: 7G1J5DA97F)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-030-01	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	02/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/06/2020

Labeler - Eai-jr 286, Inc (827896718)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Select Ltd CO		005415463	manufacture(71014-030)