Treat And Tint Skin Perfecting Bb
FDA Label NDC 54754-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sorme Company Inc for the product Treat And Tint Skin Perfecting Bb (NDC 54754-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, pediatric use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS

OCTINOXATE (6.0%)

OCTISALATE (4.5%)

AVOBENZONE (1.5%)

Otc - Purpose

PURPOSE

SUNSCREEN

Indications & Usage

USES

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES, DECREASES THE RISK OF SKIN CANCER AND SKIN AGING CAUSED BY THE SUN.

Warnings

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.

Otc - Stop Use

STOP USE AND ASK A DOCTOR 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.

Dosage & Administration

DIRECTIONS

  • APPLY AS THE LAST STEP AFTER SKIN CARE AND MAKEUP PRIMER, IF DESIRED. WEAR ALONE OR UNDER FOUNDATION.
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • 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 BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER MEASURES INCLUDING:
  • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.

Pediatric Use

CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Inactive Ingredient

INACTIVE INGREDIENTS

WATER, GLYCERIN, STEARIC ACID, VP/EICOSENE COPOLYMER, OCTYLDODECANOL, QUATERNIUM 18, HECTORITE, PROPYLENE CARBONATE, CYCLOPENTASILOXANE, POLYSORBATE 60, PENTAERYTHRITYL TETRAETHYLHEXANOATE, CETYL ALCOHOL, STEARYL ALCOHOL, PHENYL TRIMETHICONE, SORBITAN STEARATE, DIMETHICONE, BUTYLENE GLYCOL, CAPRYLYL METHICONE, POLYSILICONE 11, CETYL ESTERS, CAPRYLYL GLYCOL, PHENOXYETHANOL, HEXYLENE GLYCOL, STEARYL ALCOHOL, CETEARETH 20, CAMELLIA SINESIS LEAF EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, ALOE BARBADENSIS (ALOE) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT, PANAX GINSENG ROOT EXTRACT, PASSIFLORA INCARNATA (PASSION FRUIT) EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ARGANIA SPINOSA (ARGAN) KERNEL OIL, SODIUM HYALURONATE, ETHYLHEXYLGLYCERIN, SODIUM ACRYLATE/ACRYLOYDIMETHYL TAURATE, ISOHEXADECANE, POLYSORBATE 80, XANTHAN GUM, SODIUM HYDROXIDE, TOCOPHEROL. MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77489, CI 77491, CI 77492, CI 77499), MICA (CI 77019).

Other Safety Information

OTHER INFORMATION

PROTECT PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Otc - Questions

QUESTIONS OR COMMENTS?

CALL TOLL FREE 800-927-6763

Package Label.Principal Display Panel

Bbcream (Bbcream)

Bbcream (Bbcream)

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