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

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Active ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Purpose

Sunscreen

Uses

•helps prevent sunburn.
•if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

Directions

•apply liberally 15 minutes before sun exposure
•reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours
•children under 6 months: Ask a doctor
•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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m.–2 p.m. •wear long-sleeved shirts, pants, hats, and sun-glasses

Other Information

•protect this product from excessive heat and direct sun.

Inactive Ingredients

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


Questions or Comments

281-835-8051

Bio-Medical & Pharm. Mfg. Corp.

Package label

pro-tect spf 20 6.4 oz

spf 20

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
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-862-65190 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 DrugM02002/05/2015
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-862)

Revised: 12/2023
Document Id: 0c9399b1-9d16-f702-e063-6294a90a2802
Set id: 66bb06fb-33d2-4b57-a65f-66bcd187c627
Version: 23
Effective Time: 20231215
 
Bio-Medical & Pharmaceutical Manufacturing Corporation