BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30- octinoxate, zinc oxide, octisalate, 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, Zinc Oxide, Octisalate, Oxybenzone

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Stearyl Alcohol, Cetyl Alcohol, Squalane, Polysorbate 60, Vitamin E Tocopheryl Acetate, Pine Bark Extract, Japanese Green Tea Extract, Rosehips Extract, Licorice Extract, Sodium Edetate, Xanthan Gum, Magnesium Aluminum Silicate, Phenoxyethanol, Ethylhexyiglycerin, Hydroethylacrylate/Sodium Acryloldimethyl Copolymer, Fragrance

Suitable for normal to dry skin

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

Vitamin-enriched formula skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Helps prevent moisture loss and premature aging of the skin.

Broad spectrum UVA and UVB protection.

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;

Keep out of reach of children; If swallowed, get medical help or contact a Poison Control Center immediately

BROAD SPECTRUM SPF 30

BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30 
octinoxate, zinc oxide, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LICORICE (UNII: 61ZBX54883)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-005-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-005-0130 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: 9cd57085-9029-9388-e053-2995a90a2600
Set id: 74b061aa-7292-f41d-e053-2a91aa0a190b
Version: 3
Effective Time: 20200123
 
Only Yourx, Inc.