BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE- octinoxate, oxybenzone lotion 
Only Yourx, Inc.

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.

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Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Allantoin, Aloe Vera Powder, D-Panthenol, Sodium Edetate, Squalane, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroethylacrylate/Sodium Acryloyldimethyl Copolymer, Aminomethylpropanol

USE INSTRUCTIONS: Apply a liberal amount aproximately 30 minutes prior to sun exposure. For continuous protection, reapply regularly and after swimming and/or exercising

Broad spectrum UVA and UVB protection. Lightweight lotion suitable for even oily skin helps to protect damaging rays, moisture loss and premature aging of the skin

Broad spectrum UVA and UVB protection

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings: For external use only; Do not use on damaged or broken skin; Stop use and ask a doctor if rash occurs; When using this product keep out of eyes; Rinse with water to remove

BROAD SPECTRUM MOISTURIZING SPF 15

BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE 
octinoxate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
SQUALANE (UNII: GW89575KF9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ALLANTOIN (UNII: 344S277G0Z)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-006-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-006-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/26/2014
Labeler - Only Yourx, Inc. (089207519)

Revised: 1/2020
Document Id: 9cd57085-9020-9388-e053-2995a90a2600
Set id: 76416019-1c93-963f-e053-2a91aa0abf74
Version: 7
Effective Time: 20200123
 
Only Yourx, Inc.