Saucd Toasted Golden Tanning Spf 15 Caramel Oil
FDA Label NDC 85618-596

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Saucd General Trading Company for the product Saucd Toasted Golden Tanning Spf 15 Caramel (NDC 85618-596). 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 drug facts, active ingredients:, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:

AVOBENZONE 3%

OCTISALATE 5%

 7.5% HOMOSALATE 

Purpose

SUNSCREEN

Uses:

• HELPS PREVENT SUNBURN.
• HIGHER SPF GIVES MORE SUNBURN PROTECTION
• 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. RINSE WITH WATER TO REMOVE.

Stop Use And Ask A Doctor If

  • RASH OR IRRITATION DEVELOPS AND LASTS.

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 AND AS NEEDED.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • REAPPLY: AT LEAST EVERY 2 HOURS
  • SUN PROTECTION MEASURES.SPENDING TIME IN THE SUN INCREASE YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
    • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2P.M.
    • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

Other Information

• PROTECT THE PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients:

ALOE BARBADENSIS LEAF EXTRACT, BETA-CAROTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL*, DAUCUS CAROTA SATIVA (CARROT) SEED OIL*, DODECANE, FRAGRANCE, HYDROGENATED COCONUT OIL, IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI 77499), PRUNUS ARMENIACA (APRICOT) KERNEL OIL, RUBUS IDAEUS (RASPBERRY) SEED OIL*, SCLEROCARYA BIRREA (MARULA) SEED OIL, SILICA DIMETHYL SILYLATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, TOCOPHEROL, VITIS VINIFERA (GRAPE) SEED OIL*.     *ORGANIC

Package Labeling:

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* Please review the disclaimer below.