FDA.reportPublic FDA data

Fermitif Hand Renewal Cream Broad Spectrum SPF 15 Sunscreen

Manufacturer
RV Skincare LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:28

Label at a glance#

ProductFermitif Hand Renewal Cream Broad Spectrum SPF 15 Sunscreen
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE
Label structure8 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 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: Sun Protection Measures. limit time in t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%  Octinoxate 7.5%  Octisalate 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

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

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

  • 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
  • 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: Sun Protection Measures.
  • 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

SPL UNCLASSIFIED 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 , M - F 8am - 5pm CST. 1-888-704-3440

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package0Inner Package0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82691-148-01Fermitif Hand Renewal Cream Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM13
82691-148-01Fermitif Hand Renewal Cream Broad Spectrum SPF 15 Sunscreen100 g in 1 TUBECREAM1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82691-148FERMITIF HAND RENEWAL CREAM BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [RV SKINCARE LLC]3Legacy NDC, 2 package rows20231108_dcc68ea5-e0b7-4842-b69f-95cd11cb6194.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82691-14882691-148-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 60CAL22UVI4MIACT
SHEA BUTTERK49155WL9YIACT
PHENYLETHYL RESORCINOLG37UFG162OIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
JOJOBA BUTTERXIA46H803RIACT
MALTODEXTRIN7CVR7L4A2DIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PENTYLENE GLYCOL50C1307PZGIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SEDUM ROSEUM ROOT3S5ITS5ULNIACT
POLYSORBATE 207T1F30V5YHIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SUBTILISIN0ZP13EBC5YIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
GERANIOLL837108USYIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
SQUALANEGW89575KF9IACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL LAURATEY98611C087IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ISOHEXADECANE918X1OUF1EIACT
CARRAGEENAN5C69YCD2YJIACT
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

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
09899c87-15ba-9b6a-e063-6394a90a6be5dcc68ea5-e0b7-4842-b69f-95cd11cb61942023-11-06WarningsExact identifier
spl id: 09899c87-15ba-9b6a-e063-6394a90a6be5
spl set id: dcc68ea5-e0b7-4842-b69f-95cd11cb6194

Reported adverse events (FAERS/openFDA)#

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