Drug Labeling and Warnings

Drug Details

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PRO-TECT SUNSCREEN FOR PROFESSIONALS- meradimate, octinoxate, octisalate, oxybenzone lotion 
Bio-Medical & Pharmaceutical Manufacturing Corporation

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.

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Active ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 5.0%

Purpose

Sunscreen

Uses

Pro-Tect® SPF 30+ Broad-Spectrum UVA & UVB protection. Helps prevent sunburn. Retains a SPF of 30+ after 80 minutes of activity in water or perspiring. Provides high protection against sunburn and tanning. For skin highly sensitive to sunburn.

Warnings

External use only. 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. Do not use if sensitive to any of the ingredients or their related compounds.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

Apply this product topically to affected areas and allow to dry without rubbing. Use up to 3 times daily. Use only as directed.

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.

Other Information

Daily usage of Pro-Tect® SPF 30+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. This product provides more than 30 times your natural protection against sunburn. Very Water Resistant UVA & UVB Broad-Spectrum Protection. This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.


Questions or Comments

Bio-Medical & Pharm. Mfg. Corp., 4311 South Dr.,Houston, TX 77053-4820, 281-835-8051, M-F 8AM-5PM, www.protectsunscreen.com

Package label

SUNSCREEN FOR PROFESSIONALS

PRO-SPECTRUM PROCESS BROAD-SPECTRUM UVA/UVB SUNSCREEN

PRO-TECT

Water-Resistant

Fragrance-Free

Aloe & vitamin E

SPF 30+

5 gal Pro-Tect 30+ sunscreen18.8 kg /5 gal.

PRO-TECT SUNSCREEN FOR PROFESSIONALS 
meradimate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37945-860
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LANOLIN (UNII: 7EV65EAW6H)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MINERAL OIL (UNII: T5L8T28FGP)  
TALC (UNII: 7SEV7J4R1U)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37945-860-64100 g in 1 CONTAINER; Type 0: Not a Combination Product02/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/05/2015
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-860)

Revised: 2/2020
 
Bio-Medical & Pharmaceutical Manufacturing Corporation


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