Label: PRO-TECT SPORTS SUNSCREEN SPF 20- meradimate, octinoxate, octisalate, oxybenzone lotion
- NDC Code(s): 68605-8640-2, 68605-8640-4, 68605-8640-8
- Packager: ABBE Laboratories, Inc.
- 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 November 3, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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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 10a.m.–2 p.m.
•wear long-sleeved shirts, pants, hats, and sun-glasses - Other Information
- Inactive Ingredients
- Questions or Comments
- Package Label
-
INGREDIENTS AND APPEARANCE
PRO-TECT SPORTS SUNSCREEN SPF 20
meradimate, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68605-8640 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 mL MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL 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:68605-8640-4 118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2022 2 NDC:68605-8640-8 236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2022 3 NDC:68605-8640-2 946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2022 Labeler - ABBE Laboratories, Inc. (781745286) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(68605-8640)
