Label: RAF FIVE - KICK OFF HYDRATING BROAD SPECTRUM SPF30 SUNSCREEN- zinc oxide and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-4453-1 - Packager: Cosmetic Solutions LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 26, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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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
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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
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
RAF FIVE - KICK OFF HYDRATING BROAD SPECTRUM SPF30 SUNSCREEN
zinc oxide and titanium dioxide lotionProduct 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)
