FDA.reportPublic FDA data

Renove UV Shield Broad Spectrum SPF 50

Manufacturer
Y.S. Health Corp.
Effective date
2017-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:12

Label at a glance#

ProductRenove UV Shield Broad Spectrum SPF 50
Active ingredientOCTINOXATE, AVOBENZONE
Label structure7 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. Reapply after 80 minutes of swimming or sweating. Immediately after towel drying At least every 2 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 tim...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octinoxate 6.2%

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

OTC - DO NOT USE SECTION

damaged or broken skin

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating.
  • Immediately after towel drying
  • At least every 2 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 years of age: Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES

DICAPRYLYL CARBONATE
FRAGARIA VESCA FRUIT

GLYCERIN

SUNFLOWER SEED

WATER
CAPRYLHYDROXAMIC ACID
CAPRYLYL GLYCOL

1,2-HEXANEDIOL
LINSEED OIL
EVENING PRIMROSE OIL
CHIA SEED OIL
ACAI OIL
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
XANTHAN GUM
AMARANTHUS CAUDATUS SEED
VACHELLIA FARNESIANA WHOLE
ORANGE
GREEN TEA LEAF

Acrylates

Plankton Extract

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Renove UV ShieldRenove UV Shield

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60782-003-002020-01-31C16284748780-19d75b9d1-04d7-f424-e053-dadaa90a57ceRenove UV Shield Broad Spectrum SPF50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60782-003-00Renove UV Shield Broad Spectrum SPF 502 in 1 BOXCREAM21
60782-003-00Renove UV Shield Broad Spectrum SPF 5050 mL in 1 CONTAINERCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60782-003RENOVE UV SHIELD BROAD SPECTRUM SPF 50 (AVOBENZONE, OCTINOXATE SUNSCREEN) CREAM [Y.S. HEALTH CORP.]1Legacy NDC, 2 package rows20170310_4a2ba41b-9e73-0818-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60782-00360782-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ORANGE5EVU04N5QUIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
FRAGARIA VESCA FRUITCG6IX3GCMUIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER SEEDR9N3379M4ZIACT
WATER059QF0KO0RIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LINSEED OIL84XB4DV00WIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
CHIA SEED OILMC2LH51BO7IACT
ACAI OILZ0W6766A2WIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT
AMARANTHUS CAUDATUS SEEDFJ722PPQ9MIACT
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
VACHELLIA FARNESIANA WHOLEYPI49T6HNLIACT

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
4a2b9775-439f-2ee5-e054-00144ff8d46c4a2ba41b-9e73-0818-e054-00144ff88e882017-03-07WarningsExact identifier
spl id: 4a2b9775-439f-2ee5-e054-00144ff8d46c
spl set id: 4a2ba41b-9e73-0818-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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