Label: PRO-TECT SPORTS SUNSCREEN- meradimate, octinoxate, octisalate, oxybenzone lotion
- NDC Code(s): 37945-862-64
- Packager: Bio-Medical & Pharmaceutical Manufacturing Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Active ingredients
- Purpose
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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
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
PRO-TECT SPORTS SUNSCREEN
meradimate, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-862 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 30 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-862-64 100 g in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/27/2015 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-862)
