Tropicsurf Extreme Protection Spf30-ultra
FDA Label NDC 70884-101

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 Spf30-ultra (NDC 70884-101). 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, directions, purpose, uses, 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

Active Ingredients

  • TITANIUM DIOXIDE  4.5%
  • ZINC OXIDE            8.7%

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

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

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 Ingredients

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, CETEARYL ALCOHOL, STEARETH-2, VP/HEXADECENE COPOLYMER,

STEREATH-21, DIMETHICONE, POLYHYDROXYSTEARIC ACID, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA OLEIFERA

LEAF EXTRACT, PLEIOGYNIUM TIMORIENSE FRUIT EXTRACT, PODOCARPS ELATUS FRUIT EXTRACT, TERMINALIA FERDINANDIANA

FRUIT EXTRACT, ADANSONIA DIGITATA SEED OIL, ASTROCARYUM TUCUMA SEED BUTTER, MADACAMIA TERNIFOLIA NUT OIL,

DIPOTASSIUM GLYCYRRHIZATE, ALUMINA, STEARIC ACID, SODIUM STEAROYL GLUTAMATE, TRIETHOXYCAPRYLYLSILANE,

PROPANEDIOL, CAPRYLHYDROXAMIC ACID, DISODIUM EDTA, XANTHAN GUM, CAPRYLYL GLYCOL, ALCOHOL DENAT.,

FRAGRANCE (PARFUM)

Package Label.Principal Display Panel

Spf30 Ultra (Spf30 Ultra 6.5ozbottle 0725 Outln)

Spf30 Ultra (Spf30 Ultra 6.5ozbottle 0725 Outln)

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