FACE POTION- avobenzone, homosalate, octisalate, octocrylene lotion 
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.

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OP SPF 50 Dab on Stick

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)

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

FACE POTION 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-204-0419 g in 1 CONTAINER; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/15/2015
Labeler - SolSkyn Personal Care LLC (080010329)

Revised: 2/2018
Document Id: 623da8bb-0952-4fef-b1c6-f6d7da3b6063
Set id: b85cfad6-5f47-4a44-962b-82001363012c
Version: 2
Effective Time: 20180215
 
SolSkyn Personal Care LLC