FACE POTION- avobenzone, homosalate, octisalate, octocrylene lotion

Face Potion by

Drug Labeling and Warnings

Face 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 Dab-On Spot stick SPF 50

Drug Facts

Active Ingredients:

Avobenzone 2.5%

Active Ingredients:

Homosalate 15.0%

Active Ingredients:

Octisalate 5.0%

Active Ingredients:

Oxybenzone 6.0%

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

Stop use and ask a doctor

if rash or irritation develops.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If accidentally swallowed, contact a Poison Control Center right away.

Do not use

near heat or open flames. Keep treated skin away from fire, sparks or flames until dry.

Directions:

Apply liberally 15 minutes before sun exposure, depress sponge top to initial product application

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/Octylacrylamide Copolymer, Cholecalciferol, Denatured Alcohol, Dimethyl Capramide, Glycerin, Polyester-8

Other Information

for use on skin only. Avoid contact with fabric - protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-715-3485

PRINCIPAL DISPLAY PANEL

DAB- ON
Spot Stick Sunscreen
50 SPF
65 FL OZ (19mL)

INGREDIENTS AND APPEARANCE

FACE POTION 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ALCOHOL (UNII: 3K9958V90M)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-204-04	19 g in 1 CONTAINER; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2015

Labeler - SolSkyn Personal Care LLC (080010329)