FDA.reportPublic FDA data

OP Protect and Renew Face SPF 35

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#

ProductOP Protect and Renew Face SPF 35
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure12 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 mea...

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 Protect & Renew Face SPF 35

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15.0%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 2.7%

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl Salicylate 5.0%

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

• Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

• Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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

Caprylyl Methicone, Carbomer, Cetearyl Alcohol, Disodium EDTA, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Palmitoyl Tripeptide-5, Potassium Cetyl Phosphate, Tapioca Starch, Tocopherol, Tocopherol Acetate, Triethanolamine, Water, Xanthan Gum

Other information:

STORAGE AND HANDLING SECTION

• For use on skin only. Avoid contact with fabric.

• Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ocean Potion
Protect
& Renew
face
SPF 35
3 fl oz (89ml)

PRINCIPAL DISPLAY PANEL Ocean Potion Protect & Renew face SPF 35 3 fl oz (89ml)PRINCIPAL DISPLAY PANEL Ocean Potion Protect & Renew face SPF 35 3 fl oz (89ml)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-211-242020-09-27C16284748780-1ab0e2407-300b-f274-e053-dbdaa90a6471OP-SPF35 3oz Protect Renew Face
70281-211-242020-09-25C16284748780-1ab0e2407-300b-f274-e053-dbdaa90a6471OP-SPF35 3oz Protect Renew Face
70281-211-242020-07-22C16284748780-1ab0e2407-300b-f274-e053-dbdaa90a6471OP-SPF35 3oz Protect Renew Face

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-211-24OP Protect and Renew Face SPF 3585 g in 1 CONTAINERLOTION852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-211OP PROTECT AND RENEW FACE SPF 35 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE) LOTION [SOLSKYN PERSONAL CARE LLC]2Legacy NDC, 1 package rows20180213_8ae9eebc-426d-432e-8251-1ca45c7c0f46.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
70281-21170281-211-24

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
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
STARCH, TAPIOCA24SC3U704IIACT
TOCOPHEROLR0ZB2556P8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
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
5be8134d-9a8f-4a13-bd04-8901c67077998ae9eebc-426d-432e-8251-1ca45c7c0f462018-02-15WarningsExact identifier
spl id: 5be8134d-9a8f-4a13-bd04-8901c6707799
spl set id: 8ae9eebc-426d-432e-8251-1ca45c7c0f46

Reported adverse events (FAERS/openFDA)#

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