FDA.reportPublic FDA data

OP spf45 Lip Potion Clear Zinc

Manufacturer
SolSkyn Personal Care LLC
Effective date
2017-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:48:38

Label at a glance#

ProductOP spf45 Lip Potion Clear Zinc
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, OCTINOXATE
Label structure14 sections

Indications and uses

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Temporarily protects lips from the drying effects of wind and cold weather.

Dosage and administration

• Apply liberally before sun exposure as needed. • Children under 6 months of age: ask a doctor. • Store at room temperature.

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 spf45 1oz Lip Potion Clear Zinc

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl Salicylate 5.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 5.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Oxybenzone 5.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

• Helps prevent sunburn.

• Higher SPF gives more sunburn protection.

• Temporarily protects lips from the drying effects of wind and cold weather.

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 accidentally swallowed, contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally before sun exposure as needed.

• Children under 6 months of age: ask a doctor.

• Store at room temperature.

Inactive Ingredients: 

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Extract, Beeswas, Cocos Nucifera (Coconut Oil), Copernica Cerifera (Carnuba Wax), Euphoria Cerifera (Candelilla Wax), Flavor, Hydrogenated Vegetable Oil, Mineral Oil, Myristyl Lactate, Ozokerite, Petrolatum, Propylparaben, Saccharin, PVP/Hexadecene Copolymer

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

Moisturizing
Lip Potion
with Aloe Vera
NET WT .15 oz

PRINCIPAL DISPLAY PANEL Moisturizing Lip Potion with Aloe Vera NET WT .15 ozPRINCIPAL DISPLAY PANEL Moisturizing Lip Potion with Aloe Vera NET WT .15 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-202-032020-09-27C16284748780-1ab0e2407-3253-f274-e053-dbdaa90a6471OP Lip SPF45
70281-202-032020-09-25C16284748780-1ab0e2407-3253-f274-e053-dbdaa90a6471OP Lip SPF45
70281-202-032020-07-22C16284748780-1ab0e2407-3253-f274-e053-dbdaa90a6471OP Lip SPF45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-202-03OP spf45 Lip Potion Clear Zinc4.25 g in 1 CONTAINERSTICK4.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-202OP SPF45 LIP POTION CLEAR ZINC (AVOBENZONE, OCTYL SALICYLATE, OCTOCRYLENE, OXYBENZONE, OCTINOXATE) STICK [SOLSKYN PERSONAL CARE LLC]3Legacy NDC, 1 package rows20170128_3f71c803-19ef-4d5b-b223-473aedaf5bc6.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-20270281-202-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTINOXATE4Y5P7MUD51ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
CANDELILLA WAXWL0328HX19IACT
CORN OIL8470G57WFMIACT
MINERAL OILT5L8T28FGPIACT
MYRISTYL LACTATE1D822OC34XIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
SACCHARINFST467XS7DIACT
COPOVIDONED9C330MD8BIACT

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
8288b343-d0b7-4840-b561-afbe6a904d7b3f71c803-19ef-4d5b-b223-473aedaf5bc62017-02-01WarningsExact identifier
spl id: 8288b343-d0b7-4840-b561-afbe6a904d7b
spl set id: 3f71c803-19ef-4d5b-b223-473aedaf5bc6

Reported adverse events (FAERS/openFDA)#

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