Label: PRO-TECT EVERYDAY SUNSCREEN SPF 15- octinoxate, octisalate, padimate o lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61619-868-28 - Packager: A-Cute Derm, Incorporated
- 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 October 28, 2015
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- 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.
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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:61619-868 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61619-868-28 3800 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/03/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/03/2015 Labeler - A-Cute Derm, Incorporated (809845803) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(61619-868)