Bleve
FDA Label NDC 36800-353

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Bleve (NDC 36800-353). 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 ingredient, purpose, uses, warnings, skin cancer/skin aging alert, when using this product, stop using this product and ask a doctor if, 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 Ingredient

OCTYL METHOXYCINNAMATE 2%

AVOBENZONE 0.5%

Purpose

SKIN PROTECTANT

SKIN PROTECTANT

Uses

HELPS PREVENT SUNBURN.

Warnings

FOR EXTERNAL USE ONLY.

Skin Cancer/Skin Aging Alert

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. THIS PRODUCT HAS BEEN SHOWN ONLY TO HELP PREVENT SUNBURN, NOT SKIN CANCER OR EARLY SKIN AGING.

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Stop Using This Product And Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS.

Keep Out Of Reach Of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions

APPLY LIBERALLY 15 MINUTES BEFORE EXPOSURE TO SUN. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY TWO HOURS. FOR CHILDREN UNDER 6 MONTHS, ASK A DOCTOR.

Inactive Ingredients

WATER (AQUA), CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, GLYCINE SOJA (SOYBEAN) OIL, C12-15 ALKYL BENZOATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, GLYCERYL STEARATE, CETYL ALCOHOL, STEARYL ALCOHOL, DIMETHICONE,VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, ISOMALT, LECITHIN, SODIUM BENZOATE, PALMITOYL TRIPEPTIDE-38, GLYCERIN, HYDROXYPROPYL CYCLODEXTRIN, INULIN, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE (PARFUM), PHENOXYETHANOL, TROPOLONE.

Label Copy

Image Of The Label (Brdl01)

Image Of The Label (Brdl01)

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