FDA.reportPublic FDA data

RAF™ Five - Kick Off Hydrating Lotion BROAD SPECTRUM SPF30 SUNSCREEN

Manufacturer
Cosmetic Solutions LLC
Effective date
2021-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:08

Label at a glance#

ProductRAF Five - Kick Off Hydrating BROAD SPECTRUM SPF30 SUNSCREEN
Active ingredientZinc Oxide, Titanium Dioxide
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and spread evenly 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 broad spectrum SPF of 15 or higher and other sun protection measures including: Lim...

Storage and handling

Protect this product from excessive heat and direct sun. Store at room temperature (59-85°).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.0%
Zinc Oxide 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor.

  • If irritation or 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

  • Apply liberally and spread evenly 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am - 2 pm.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun. Store at room temperature (59-85°).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/ Capric Triglyceride, Undecane, Pentylene Glycol, Steareth-2 Glycerin, Cetearyl Alcohol, Niacinamide, PPG-12/SMDI Copolymer, Silica, Steareth -21 Tridecane, Polyhydroxystearic Acid, Propanediol, Cannabidiol, Ergothioneine, Dipotassium Glycyrrhizate, Zingiber Officinale (Ginger) Root Extract, Artemisia Vulgaris Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Mentha Citrata Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Vitis Vinifera (Grape) Seed Oil, Sodium Hyaluronate, Bisabolol, Alumina, Stearic Acid.

SPL UNCLASSIFIED SECTION

Distributed by ILERA DERM LLC,
a subsidiary of Zelira Therapeutics LTD.
5110 Campus Drive Plymouth Meeting, PA 19462

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAF™
FIVE

KICK OFF
HYDRATING LOTION

BROAD SPECTRUM
SPF30
SUNSCREEN

with CBD

1.7 fl. oz. / 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-4453-12023-01-30C16284748780-1f386c64a-10c4-0266-e053-dadaa90a7c1aRAF™ Five - Kick Off Hydrating Lotion BROAD SPECTRUM SPF30 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-4453-1RAF Five - Kick Off Hydrating BROAD SPECTRUM SPF30 SUNSCREEN50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-4453RAF FIVE - KICK OFF HYDRATING BROAD SPECTRUM SPF30 SUNSCREEN (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20210829_975a90a6-b606-466e-a292-1d22dba40ea4.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-445366163-4453-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
UndecaneJV0QT00NUEIACT
Pentylene Glycol50C1307PZGIACT
Steareth-2V56DFE46J5IACT
GlycerinPDC6A3C0OXIACT
Cetostearyl Alcohol2DMT128M1SIACT
Niacinamide25X51I8RD4IACT
PPG-12/SMDI Copolymer1BK9DDD24EIACT
Silicon DioxideETJ7Z6XBU4IACT
Steareth-2153J3F32P58IACT
TridecaneA3LZF0L939IACT
Propanediol5965N8W85TIACT
Cannabidiol19GBJ60SN5IACT
ErgothioneineBDZ3DQM98WIACT
Glycyrrhizinate DipotassiumCA2Y0FE3FXIACT
GingerC5529G5JPQIACT
Artemisia Vulgaris Top Oil72Q967Y48VIACT
Bergamot Oil39W1PKE3JIIACT
Lemon Oil, Cold PressedI9GRO824LLIACT
Eucalyptus Oil2R04ONI662IACT
Juniperus Virginiana OilPAD4FN7P2GIACT
Spearmint OilC3M81465G5IACT
Grape Seed Oil930MLC8XGGIACT
Hyaluronate SodiumYSE9PPT4THIACT
Levomenol24WE03BX2TIACT
Aluminum OxideLMI26O6933IACT
Stearic Acid4ELV7Z65APIACT

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
86da4fd2-ae11-4c7e-8e37-5d78b77e3a54975a90a6-b606-466e-a292-1d22dba40ea42021-08-26WarningsExact identifier
spl id: 86da4fd2-ae11-4c7e-8e37-5d78b77e3a54
spl set id: 975a90a6-b606-466e-a292-1d22dba40ea4

Reported adverse events (FAERS/openFDA)#

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