PRO-TECT EVERYDAY SUNSCREEN  SPF 15- octinoxate, octisalate, padimate o 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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Pro-Tect Everyday Sunscreen SPF 15

DRUG FACTS

Pro-Tect® SPF 15+ Sunscreen Broad-Spectrum UVA/UVB Protection & Moisturizing Lotion

Active Ingredients

Octinoxate...........................................................7.5%

Oxybenzone.........................................................2.0%

Padimate O...........................................................5.0%

Purpose

Sunscreen

Uses

•Pro-Tect® SPF 15+ Broad-Spectrum UVA & UVB protection. •Helps prevent sunburn. •Retains a SPF of 15+ after 80 minutes of activity in water of 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 of their related compounds.

​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, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Trolamine, Water.

Other Information

•Daily usage of Pro-Tect SPF15+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. •This product provides more than 15 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

Principal Display Panel -
Pro-Tect Everyday Sunscreen
SPF 15
190 grams
NDC:37945-868-65

0e256f99-a3bf-648b-e054-00144ff8d46c.jpg Label

PRO-TECT EVERYDAY SUNSCREEN   SPF 15
octinoxate, octisalate, padimate o lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-868
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-868-06207.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/198702/05/2015
2NDC:37945-868-65190 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/1987
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-868)

Revised: 2/2015
Document Id: 0eae8a83-5536-5611-e054-00144ff88e88
Set id: 1fbe0198-177d-4e6d-a103-cc2d75ef5cbb
Version: 10
Effective Time: 20150209
 
Bio-Medical & Pharmaceutical Manufacturing Corporation