Label: MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN- zinc oxide lotion
- NDC Code(s): 81409-001-01, 81409-001-02
- Packager: Maui Vera, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
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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
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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
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- Package Labeling: 89ml
- Package Labeling: 192ml
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INGREDIENTS AND APPEARANCE
MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN
zinc oxide lotionProduct 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)