Label: PRO-TECT SPORTS SUNSCREEN- meradimate, octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 37945-862-64 - 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 July 28, 2021
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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
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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 not final part352 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)
