Drug Labeling and Warnings

Drug Details

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PRO-TECT SPORTS SUNSCREEN- 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 3.0%

Purpose

Sunscreen

Uses

Pro-Tect® SPF 20+ Broad-Spectrum UVA & UVB protection. Helps prevent sunburn. Retains a SPF of 20+ 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 liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed. Children under 6 months of age: ask a doctor.

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.

Other Information

Daily usage of Pro-Tect SPF20+ may help reduce the chance of premature aging of the skin due to

overexposure to the sun. This product provides more than 20 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.bio-medicalmanufacturing.com

Package label

3-4-oz-Pro-Tect-SPF-20+-Sunscreen

Principal Display Panel

Pro-Tect Sports Suns creen

SPF 20

100 grams

NDC: 37945-862-64

PRO-TECT SPORTS SUNSCREEN 
meradimate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37945-862
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) OXYBENZONE30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37945-862-64100 g in 1 BOTTLE; Type 0: Not a Combination Product05/27/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2015
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-862)

Revised: 5/2015
 
Bio-Medical & Pharmaceutical Manufacturing Corporation


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