PURPOSE- octinoxate, octisalate and oxybenzone lotion 
Bausch Health US LLC

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 Facts

Active ingredients

Octinoxate 7.5%
Octisalate 5%
Oxybenzone 3%




helps prevent sunburn


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.

If product is swallowed, get medical help or contact a Poison Control Center right away.


■ apply generously and evenly 15 minutes before sun exposure

■ apply to all skin exposed to the sun

■ use a water resistant sunscreen if swimming or sweating

■ reapply at least every 2 hours

■ children under 6 months of age:

    Ask a doctor

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

water, octyldodecyl neopentanoate, glycerin, emulsifying wax NF, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, diazolidinyl urea, carbomer, methylparaben, ethylparaben, propylparaben, bisabolol, farnesol, citric acid



Package/Label Principal Display Panel – 118 ml Carton


Dual Treatment
Moisture Lotion

SPF 10


Fragrance Free




Developed with


4 FL. OZ. (118 mL)

octinoxate, octisalate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate76 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5500-041 in 1 CARTON10/07/2013
1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/07/2013
Labeler - Bausch Health US LLC (831922468)
NameAddressID/FEIBusiness Operations
KIK Custom Product - Rexdale Plant243547333MANUFACTURE(0187-5500)

Revised: 8/2020
Document Id: 25ecf41f-85d3-4f2b-9e4d-8ec40d6474d1
Set id: 7dc62571-2ada-4bb3-a9c7-c51d3dced9c6
Version: 4
Effective Time: 20200819
Bausch Health US LLC