Label: PRO-TECT SUNSCREEN FOR PROFESSIONALS- meradimate, octinoxate, octisalate, oxybenzone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 37945-860-50 - Packager: Bio-Medical & Pharmaceutical Manufacturing Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 5, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
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
- Package label
-
INGREDIENTS AND APPEARANCE
PRO-TECT SUNSCREEN FOR PROFESSIONALS
meradimate, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-860 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-860-50 1880 g in 1 CONTAINER; Type 0: Not a Combination Product 05/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/15/2015 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-860)
18.8 kg /5 gal.