MAUI VERA MINERAL SUNSCREEN SPF LAVENDER AND PEPPERMINT- zinc oxide cream

Maui Vera Mineral Sunscreen SPF Lavender and Peppermint by

Drug Labeling and Warnings

Maui Vera Mineral Sunscreen SPF Lavender and Peppermint by is a Otc medication manufactured, distributed, or labeled by Maul Vera, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Uncoated Zinc Oxide 20%

Purpose

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 children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply: after 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• 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 time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses

• Children under 6 months: Ask a doctor

Other information

Protect the product and this container from excessive heat and direct sun.

Inactive ingredients

*Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglycerides, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, *Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Propanediol, Xanthan Gum, Sclerotium Gum, Pullulan, Dehydroacetic Acid (and) Benzyl Alcohol, Polyhydroxystearic Acid, Silica, Cetyl Alcohol, *Arnica montana (Arnica) Extract, *Camellia sinensis (Green Tea) Extract, *Morinda Citrifolia (Noni Fruit), *Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil * Organic Ingredints

Questions or comments?

1-415-938-7808

Package Labeling:

INGREDIENTS AND APPEARANCE

MAUI VERA MINERAL SUNSCREEN SPF LAVENDER AND PEPPERMINT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81409-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
AVOCADO OIL (UNII: 6VNO72PFC1)
SHEA BUTTER (UNII: K49155WL9Y)
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ALCOHOL (UNII: 936JST6JCN)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
NONI FRUIT (UNII: 7829X3G2X5)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81409-000-00	89 mL in 1 TUBE; Type 0: Not a Combination Product	05/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/24/2024

Labeler - Maul Vera, Inc. (019591508)