FDA.reportPublic FDA data

OP spf45 Face Clear Zinc Potion

Manufacturer
SolSkyn Personal Care LLC
Effective date
2018-02-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:30

Label at a glance#

ProductOP spf45 Face Clear Zinc Potion
Active ingredientOCTINOXATE, ZINC OXIDE, OXYBENZONE, OCTISALATE, OCTOCRYLENE
Label structure14 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. 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...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OP spf45 1oz Face Clear Zinc Potion

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 7.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Oxybenzone 5.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 2.0%

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 on damaged or broken skin.

OTC - DO NOT USE SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - WHEN USING SECTION

Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • 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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-203-002020-09-27C16284748780-1ab0e2407-2dea-f274-e053-dbdaa90a6471OP Face 45 Zinc
70281-203-002020-09-25C16284748780-1ab0e2407-2dea-f274-e053-dbdaa90a6471OP Face 45 Zinc
70281-203-002020-07-22C16284748780-1ab0e2407-2dea-f274-e053-dbdaa90a6471OP Face 45 Zinc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-203-00OP spf45 Face Clear Zinc Potion28.35 g in 1 CONTAINERCREAM28.353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-203OP SPF45 FACE CLEAR ZINC POTION (OCTINOXATE, ZINC OXIDE, OXYBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [SOLSKYN PERSONAL CARE LLC]3Legacy NDC, 1 package rows20180213_5ac266e4-7471-42d0-bf1c-c792714129c0.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-20370281-203-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DIMETHICONE92RU3N3Y1OIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITYL LAURATE23XPH3M9LRIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

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
e51883b7-26b8-41c3-bb34-0475a5dd8b535ac266e4-7471-42d0-bf1c-c792714129c02018-02-15WarningsExact identifier
spl id: e51883b7-26b8-41c3-bb34-0475a5dd8b53
spl set id: 5ac266e4-7471-42d0-bf1c-c792714129c0

Reported adverse events (FAERS/openFDA)#

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