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

RAF Five - Kick Off Hydrating BROAD SPECTRUM SPF30 SUNSCREEN by

Drug Labeling and Warnings

RAF Five - Kick Off Hydrating BROAD SPECTRUM SPF30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

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.

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

RAF™
FIVE

KICK OFF
HYDRATING LOTION

BROAD SPECTRUM
SPF30
SUNSCREEN

with CBD

1.7 fl. oz. / 50 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-4453
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7.5 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-4453-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2021

Labeler - Cosmetic Solutions LLC (807907928)