MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN- zinc oxide lotion

Maui Vera Reef Friendly Mineral Sunscreen by

Drug Labeling and Warnings

Maui Vera Reef Friendly Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Maui Vera, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every2 hours
• Use a water resistant sunscreen if swimming or sweating 
• 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: Sun Protection Measures.
• 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 of age: Ask a doctor

Other information

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

Inactive ingredients

*Aloe Barbadensis Leaf (Aloe) Juice, *Caprylic/Capric Triglyceride, (Coconut Oil),Cetearyl Olivate, Sorbitane Olivate, Cetearyl Alcohol, Cetyl Alcohol, *Persea Americana (Avocado) Oil, Panthenol (Vitamin B-5), Lauroyl Lysin, Vitamin E Acetate, Polyhydroxy Stearic Acid, Benzyl Alcohol, Dehydroacetic Acid, Xanthan Gum, Sodium Phytate *Organic Ingredients

Questions or comments?

1-415-938-7808

Package Labeling: 89ml

Package Labeling: 192ml

INGREDIENTS AND APPEARANCE

MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81409-001
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)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
AVOCADO (UNII: SDS87L369F)
PANTHENOL (UNII: WV9CM0O67Z)
LAUROYL LYSINE (UNII: 113171Q70B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTATE SODIUM (UNII: 88496G1ERL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81409-001-01	89 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2021
2	NDC: 81409-001-02	192 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2021

Labeler - Maui Vera, Inc. (019591508)