RAF FIVE - KICK OFF HYDRATING BROAD SPECTRUM SPF30 SUNSCREEN- zinc oxide and titanium dioxide lotion 
Cosmetic Solutions LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Drug Facts

Active Ingredients

Titanium Dioxide 6.0%
Zinc Oxide 7.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only

When using this product

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

Stop use and ask a doctor.

  • If irritation or rash occurs.

Keep out of reach of children.

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

Directions

Reapply:

Sun Protection Measures:

Other information

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

Inactive ingredients

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.

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

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
RAF FIVE - KICK OFF HYDRATING BROAD SPECTRUM SPF30 SUNSCREEN 
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4453
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.5 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Undecane (UNII: JV0QT00NUE)  
Pentylene Glycol (UNII: 50C1307PZG)  
Steareth-2 (UNII: V56DFE46J5)  
Glycerin (UNII: PDC6A3C0OX)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Niacinamide (UNII: 25X51I8RD4)  
PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Steareth-21 (UNII: 53J3F32P58)  
Tridecane (UNII: A3LZF0L939)  
Propanediol (UNII: 5965N8W85T)  
Cannabidiol (UNII: 19GBJ60SN5)  
Ergothioneine (UNII: BDZ3DQM98W)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Ginger (UNII: C5529G5JPQ)  
Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V)  
Bergamot Oil (UNII: 39W1PKE3JI)  
Lemon Oil, Cold Pressed (UNII: I9GRO824LL)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Juniperus Virginiana Oil (UNII: PAD4FN7P2G)  
Spearmint Oil (UNII: C3M81465G5)  
Grape Seed Oil (UNII: 930MLC8XGG)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Levomenol (UNII: 24WE03BX2T)  
Aluminum Oxide (UNII: LMI26O6933)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-4453-150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2021
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 8/2021
Document Id: 86da4fd2-ae11-4c7e-8e37-5d78b77e3a54
Set id: 975a90a6-b606-466e-a292-1d22dba40ea4
Version: 1
Effective Time: 20210826
 
Cosmetic Solutions LLC