VERTRA MICK FANNING SIGNATURE FOUNDATION SUNSCREEN FACE STICK SPF 35 COOLANGATTA BEIGE- titanium dioxide stick

Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige by

Drug Labeling and Warnings

Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige by is a Otc medication manufactured, distributed, or labeled by EAI-JR 286, Inc., Toshiki Pigment Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 23%..............Sunscreen

PURPOSE

• 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.
• Higher SPF gives more sunburn protection.
• Retains SPF after 80 minutes activity in the water, sweating or perspiring.
• Provides high protection against sunburn.

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 or irritation develops and lasts.

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

• Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours.
• Children under 6 months of age: ask a doctor.
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit your time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours

INACTIVE INGREDIENT

Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate, Fragrance

STORAGE AND HANDLING

Protect this product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

vertra

35

Coolangatta Beige Face Stick

Mineral Based Foundation

Broad Spectrum SPF35

Water Resistant (80 Minutes)

11g NET WT. 0.39 OZ

INGREDIENTS AND APPEARANCE

VERTRA MICK FANNING SIGNATURE FOUNDATION SUNSCREEN FACE STICK SPF 35 COOLANGATTA BEIGE 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
MICA (UNII: V8A1AW0880)
STEARIC ACID (UNII: 4ELV7Z65AP)
CERESIN (UNII: Q1LS2UJO3A)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PARAFFIN (UNII: I9O0E3H2ZE)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-090-01	11 g in 1 CARTON; Type 0: Not a Combination Product	01/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/27/2021

Labeler - EAI-JR 286, Inc. (827896718)

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Co., Ltd.		716140285	manufacture(71014-090)