Medication Guide App

bleve bvibrant

Dosage form: lotion
Ingredients: OCTINOXATE 2mL in 100mL, AVOBENZONE 0.5mL in 100mL
Labeler: TOPCO ASSOCIATES LLC
NDC Code: 36800-353

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

BLEVE  BVIBRANT
octyl methoxycinnamate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-353
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES 
SOYBEAN OIL 
ALKYL (C12-15) BENZOATE 
POLYGLYCERIN-3 
GLYCERYL MONOSTEARATE 
CETYL ALCOHOL 
STEARYL ALCOHOL 
DIMETHICONE 
VITIS VINIFERA FLOWERING TOP 
ISOMALT 
LECITHIN, SOYBEAN 
SODIUM BENZOATE 
PALMITOYL TRIPEPTIDE-5 
GLYCERIN 
HYDROXYPROPYLBETADEX (0.58-0.68 MS) 
INULIN 
CARBOMER COPOLYMER TYPE A 
PHENOXYETHANOL 
TROPOLONE 
Packaging
#Item CodePackage Description
1NDC:36800-353-04118 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/19/2012
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 03/2012
 
TOPCO ASSOCIATES LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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