Label: PURPOSE- octinoxate, octisalate and oxybenzone lotion
- NDC Code(s): 0187-5500-04
- Packager: Bausch Health US LLC
- Category: HUMAN OTC DRUG LABEL
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.
Updated August 19, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Active ingredients
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
- Keep out of reach of children.
- Other information
- Inactive ingredients
- Package/Label Principal Display Panel – 118 ml Carton
INGREDIENTS AND APPEARANCE
octinoxate, octisalate and oxybenzone lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0187-5500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 76 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Octyldodecyl Neopentanoate (UNII: X8725R883T) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Dimethicone (UNII: 92RU3N3Y1O) Trolamine (UNII: 9O3K93S3TK) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Methylparaben (UNII: A2I8C7HI9T) Ethylparaben (UNII: 14255EXE39) Propylparaben (UNII: Z8IX2SC1OH) Levomenol (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0187-5500-04 1 in 1 CARTON 10/07/2013 1 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/07/2013 Labeler - Bausch Health US LLC (831922468) Establishment Name Address ID/FEI Business Operations KIK Custom Product - Rexdale Plant 243547333 MANUFACTURE(0187-5500)