Label: PRO-TECT EVERYDAY SUNSCREEN SPF 15- octinoxate, octisalate, padimate o lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 37945-868-06, 37945-868-65 - 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 9, 2015
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
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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
- Principal Display Panel - Pro-Tect Everyday Sunscreen SPF 15 190 grams NDC:37945-868-65
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INGREDIENTS AND APPEARANCE
PRO-TECT EVERYDAY SUNSCREEN SPF 15
octinoxate, octisalate, padimate o lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-868 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 g PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 50 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-868-06 207.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/1987 02/05/2015 2 NDC:37945-868-65 190 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2015 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/1987 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-868)