FDA.reportPublic FDA data

Face Potion

Manufacturer
SolSkyn Personal Care LLC
Effective date
2018-02-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:31

Label at a glance#

ProductFace Potion
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Indications and 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

Dosage and administration

• 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...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OP Dab-On Spot stick SPF 50

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15.0%

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5.0%

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Oxybenzone 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

• 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:

WARNINGS SECTION

• For external use only.

• Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

• Stop use and ask a doctor

OTC - STOP USE SECTION

if rash or irritation develops.

• When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

• Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

• Do not use

OTC - DO NOT USE SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Other Information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-715-3485

PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-204-042020-09-27C16284748780-1ab0e2407-2df0-f274-e053-dbdaa90a6471OP SPF 50 Dab on Stick
70281-204-042020-09-25C16284748780-1ab0e2407-2df0-f274-e053-dbdaa90a6471OP SPF 50 Dab on Stick
70281-204-042020-07-22C16284748780-1ab0e2407-2df0-f274-e053-dbdaa90a6471OP SPF 50 Dab on Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-204-04Face Potion19 g in 1 CONTAINERLOTION192

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-204FACE POTION (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC]2Legacy NDC, 1 package rows20180213_b85cfad6-5f47-4a44-962b-82001363012c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-20470281-204-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CHOLECALCIFEROL1C6V77QF41IACT
ALCOHOL3K9958V90MIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
GLYCERINPDC6A3C0OXIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
623da8bb-0952-4fef-b1c6-f6d7da3b6063b85cfad6-5f47-4a44-962b-82001363012c2018-02-15WarningsExact identifier
spl id: 623da8bb-0952-4fef-b1c6-f6d7da3b6063
spl set id: b85cfad6-5f47-4a44-962b-82001363012c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.