Sun Bathe Sunscreen
FDA Label NDC 70342-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baby Bubba Enterprises Inc for the product Sun Bathe Sunscreen (NDC 70342-102). 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, otc - stop use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

AVOBENZONE    1.6%

OCTINOXATE    5.2%

OCTOCRYLENE    4.2%

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

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.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION OCCURS.

Directions

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY:
  • AT LEAST EVERY 2 HOURS

    • 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 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

    • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
    • WEAR LONG SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES.
      • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Other Information

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

Inactive Ingredients

WATER, PROPYLENE GLYCOL, SODIUM STEARATE, GLYCERIN, SODIUM LAURETH SULFATE, SORBITOL, SODIUM LAURYL SULFATE, SODIUM MYRISTATE, SODIUM COCOYL ISETHIONATE, ACRYLATES COPOLYMER, FRAGRANCE (PARFUM), TRIETHANOLAMINE, TITANIUM DIOXIDE (CI 77891), POLYQUATERNIUM-16, SILICA, TETRASODIUM ETIDRONATE, PENTASODIUM PENTETATE, YELLOW 10 (CI 47005), POLYAMIDE-3, SORBITAN OLEATE, POLYSORBATE 20, CELLULOSE GUM, PEG-16, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, PG-HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN.

Questions Or Comments?

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