FDA.reportPublic FDA data

RéVive Fermitif™ Hand Renewal Cream Broad Spectrum SPF 15 Sunscreen

Manufacturer
RéVive Skincare
Effective date
2018-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:16

Label at a glance#

ProductReVive Fermitif Hand Renewal Broad Spectrum SPF 15 Sunscreen
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE
Label structure9 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

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply 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 t...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Octinoxate 7.5%Sunscreen
Octisalate 2.0%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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use:
    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply 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 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Mangifera Indica (Mango) Seed Butter, Octyldodecyl Neopentanoate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Aluminum Starch Octenylsuccinate, Hydrogenated Palm Glycerides, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Decapeptide-4, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Sodium Coco PG-Dimonium Chloride Phosphate, Caprylyl Methicone, Squalane, Camellia Sinensis Seed Oil, Caprylyl Glycol, Fragrance, Glyceryl Laurate, Polysilicone-11, Isohexadecane, Carrageenan, Glucose, Polyethylene, Tocopheryl Acetate, Polysorbate 60, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Phenylethyl Resorcinol, Potassium Jojobate, Potassium Sorbate, Propanediol, Simmondsia Chinensis (Jojoba) Butter, Maltodextrin, Disodium EDTA, Pentylene Glycol, Carbomer, Rhodiola Rosea Root Extract, Polysorbate 20, Sodium Hyaluronate, Subtilisin, Citronellol, Geraniol. May Contain (+/-): Red 4, Red 33.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-704-3440, M – F 8am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FERMITIF™
HAND RENEWAL CREAM

RéVive

Broad Spectrum
SPF 15 Sunscreen

100 g / net wt. 3.4 oz.

Principal Display Panel - 100 g Tube Carton
Principal Display Panel - 100 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-415-602020-01-31C16284748780-19d75b9d0-ec4d-f424-e053-dadaa90a57ceRéVive Fermitif™ Hand Renewal Cream Broad Spectrum SPF 15 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-415-60ReVive Fermitif Hand Renewal Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM11
58411-415-60ReVive Fermitif Hand Renewal Broad Spectrum SPF 15 Sunscreen100 g in 1 TUBECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-415REVIVE FERMITIF HAND RENEWAL BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, OCTINOXATE, AND OCTISALATE) CREAM [RÉVIVE SKINCARE]1Legacy NDC, 2 package rows20180129_63b61bfc-df73-4ec8-a73b-d3e18274f431.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-41558411-415-60

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
DIMETHICONE92RU3N3Y1OIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
SQUALANEGW89575KF9IACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL LAURATEY98611C087IACT
ISOHEXADECANE918X1OUF1EIACT
CARRAGEENAN5C69YCD2YJIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 60CAL22UVI4MIACT
SHEA BUTTERK49155WL9YIACT
PHENYLETHYL RESORCINOLG37UFG162OIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
JOJOBA BUTTERXIA46H803RIACT
MALTODEXTRIN7CVR7L4A2DIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYSORBATE 207T1F30V5YHIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SUBTILISIN0ZP13EBC5YIACT
GERANIOLL837108USYIACT
FD&C RED NO. 4X3W0AM1JLXIACT

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
96f336ad-cb08-4b6e-b7f7-51362660106363b61bfc-df73-4ec8-a73b-d3e18274f4312018-01-22WarningsExact identifier
spl id: 96f336ad-cb08-4b6e-b7f7-513626601063
spl set id: 63b61bfc-df73-4ec8-a73b-d3e18274f431

Reported adverse events (FAERS/openFDA)#

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