OP SPF45 FACE CLEAR ZINC POTION- octinoxate, zinc oxide, oxybenzone, octisalate, octocrylene cream

OP spf45 Face Clear Zinc Potion by

Drug Labeling and Warnings

OP spf45 Face Clear Zinc Potion by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• Helps prevent sunburn
  
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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:

• Apply liberally 15 minutes before sun exposure.
  
• Re-apply:
  after 80 minutes of swimming or sweating
  immediately after towel drying
  at least every two hours
  
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  limit time in the sun, especially from 10 a.m.-2 p.m.
  wear long-sleeved shirts, pants, hats and sunglasses
  Children under 6 months: ask a doctor.

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

• Protect this product from excessive heat and direct sun.

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)

INGREDIENTS AND APPEARANCE

OP SPF45 FACE CLEAR ZINC POTION 
octinoxate, zinc oxide, oxybenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-203-00	28.35 g in 1 CONTAINER; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2017

Labeler - SolSkyn Personal Care LLC (080010329)