Ole Henriksen Banana Bright Mineral Sunscreen Lotion
FDA Label NDC 71499-045

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kendo Holdings Inc for the product Ole Henriksen Banana Bright Mineral Sunscreen (NDC 71499-045). 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, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

ZINC OXIDE 16.32%

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.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Otc - Keep Out Of Reach Of Children

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.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • CHILDREN UNDER 6 MONTHS: 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 SUNCREEN 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.

Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients

WATER, MEDIUM-CHAIN TRIGLYCERIDES, BUTYLOCTYL SALICYLATE, PROPANEDIOL, NIACINAMIDE, ALOE VERA LEAF, 1,2-HEXANEDIOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, TETRAHEXYLDECYL ASCORBATE, ORANGE, ORANGE PEEL, LIMOSILACTOBACILLUS FERMENTUM, PANTHENOL, TOCOPHEROL, GLUCONOLACTONE,

GLYCERIN, JOJOBA ESTERS, SUNFLOWER OIL, GLYCERYL MONOSTEARATE, CETYL ALCOHOL, CALCIUM GLUCONATE, GLYCOL STEARATE, LECITHIN, SORBITAN MONOOLEATE, STARCH, HYDROXYACETOPHENONE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, ISOHEXADECANE, XANTHAN GUM, CANOLA OIL, POLYSORBATE 80, POTASSIUM SORBATE, SODIUM BENZOATE, CITRIC ACID, OCTYLDODECANOL, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, CITRAL, LIMONENE, LINALOOL, TITANIUM DIOXIDE, IRON OXIDES

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