Tropicsurf Extreme Protection Spf50
FDA Label NDC 70884-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Palmer Surf Llc (dba X3embrands) for the product Tropicsurf Extreme Protection Spf50 (NDC 70884-102). 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 otc - active ingredient, dosage & administration, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

  • OCTOCRYLENE  7.5%
  • ZINC OXIDE      10.5%

Dosage & Administration

DIRECTIONS

  • APPLY LIBERALLY 15 MINUTES PRIOR TO SUN EXPOSURE. REAPPLY AFTER
  • 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL
  • DRYING; AND, AT LEAST EVERY 2 HOURS.

    • SUN PROTECTION MEASURES:

    • SPENDING TIME IN THE SUN INCREASES YOUR RISKI 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 AM TO 2 PM; WEAR
    • LONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES; CHILDREN UNDER 6 MOS.
    • OF AGE, ASK A DOCTOR

Otc - Purpose

PURPOSE:

  • SUNSCREEN

Indications & Usage

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

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN

Otc - When Using

WHEN USING THIS PRODUCT

  • KEEP OUT OF THE EYES.
  • RINSE WITH WATER TO REMOVE

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF

  • 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 A POISON CONTROL CENTER RIGHT AWAY.

Inactive Ingredient

INACTIVE INGREDIENTS:

WATER/AQUA/EAU, OCTYLDODECYL NEOPENTANOATE, DIMETHICONE, CETEARYL ALCOHOL, ACRYLATES COPOLYMER,

PEG-100 STEARATE, GLYCERYL STEARATE, PENTYLENE GLYCOL, PHENYL TRIMETHICONE, GLYCERIN, CYCLOPENTASILOXANE,

TRIMETHYLSILOXYSILICATE, PEG-40 STEARATE, ALOE BARBADENSIS LEAF JUICE, CAMELLIA OLEIFERA LEAF JUICE,

ASTROCARYUM TUCUMA SEED BUTTER, MACADAMIA TERNIFOLIA SEED OIL, ADANSONIA DIGITATA SEED OIL, MANGIFERA

INDICA (MANGO) SEED BUTTER, COCO GLUCOSIDE, TOCOPHERYL ACETATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL

TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, POLYSILICONE-11, SODIUM POLYACRYLATE, XANTHAN GUM,

DICETYL PHOSPHATE, CETTH-10 PHOSPHATE, AMINOMETHYLPROPANOL, DISODIUM EDTA, CAPRYLYL GLYCOL, PHENOXYETHANOL,

CHLOPHENESIN, BENXYL CINNAMATE, COUMARIN, LIMONENE, HEXYL CINNAMAL, FRAGRANCE (PARFUM)

Package Label.Principal Display Panel

Spf50 (Spf50 6.5ozbottle 0725 Outlin)

Spf50 (Spf50 6.5ozbottle 0725 Outlin)

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