OP SPF45 FACE CLEAR ZINC POTION- octinoxate, zinc oxide, oxybenzone, octisalate, octocrylene cream 
SolSkyn Personal Care 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.

----------

OP Face 45 Zinc

OP spf45 1oz Face Clear Zinc Potion

Active Ingredients

Octinoxate 7.5%

Active Ingredients

Zinc Oxide 7.0%

Active Ingredients

Oxybenzone 5.0%

Active Ingredients

Octisalate 5.0%

Active Ingredients

Octocrylene 2.0%

Purpose

Sunscreen

Uses:

Warnings:

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.

Directions:

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzote, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Methylparaben, Propylene Glycol, Propylparaben, Sorbitan Stearate, Sorbityl Laurate, Stearyl Alcohol, Triethoxycaprylylsilane, Water, Xanthan Gum

Other Information

Questions or comments?

Call toll free 1-800-715-3485

PRINCIPAL DISPLAY PANEL

Clear Zinc Oxide
Face Potion
sunscreen
Net WT. 1.0 OZ (28.5 g)

PRINCIPAL DISPLAY PANEL
Clear Zinc Oxide
Face Potion
sunscreen
Net WT. 1.0 OZ (28.5 g)

OP SPF45 FACE CLEAR ZINC POTION 
octinoxate, zinc oxide, oxybenzone, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SORBITYL LAURATE (UNII: 23XPH3M9LR)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-203-0028.35 g in 1 CONTAINER; Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2017
Labeler - SolSkyn Personal Care LLC (080010329)

Revised: 2/2018
Document Id: e51883b7-26b8-41c3-bb34-0475a5dd8b53
Set id: 5ac266e4-7471-42d0-bf1c-c792714129c0
Version: 3
Effective Time: 20180215
 
SolSkyn Personal Care LLC