Buttah Tinted Mineral Sunscreen Lotion
FDA Label NDC 82069-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Buttah Enterprises, Llc. for the product Buttah Tinted Mineral Sunscreen (NDC 82069-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6%

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 DAMAGE 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

  • APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
  •      LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM.
  •      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
  •      CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.

Storage And Handling

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Questions Or Comments

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