1. Home
  2. Labeler Index
  3. Palmer Surf Llc (dba X3embrands)
  4. 70884-102
  5. Label Information: Tropicsurf Extreme Protection Spf50

FDA Label for Tropicsurf Extreme Protection Spf50

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. DOSAGE & ADMINISTRATION
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tropicsurf Extreme Protection Spf50 Product Label

The following document was submitted to the FDA by the labeler of this product Palmer Surf Llc (dba X3embrands). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.