REN CLEAN FAVOURITES- zinc oxide kit

REN Clean Favourites by

Drug Labeling and Warnings

REN Clean Favourites by is a Otc medication manufactured, distributed, or labeled by REN Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 22%

Purpose

Sunscreen

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.

Warnings

For External Use Only

Do not use

• On damaged or broken skin

When using this product

• Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• Rash occurs.

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure 
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor

Other information 

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Aqua (Water), Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Glycerin, Caprylyl Caprylate/Caprate, Propanediol, Arachidyl Alcohol, Cetearyl Alcohol, Coco-Glucoside, Oryza Sativa Starch, Pongamia Glabra Seed Oil, Microcrystalline Cellulose, Behenyl Alcohol, Phenoxyethanol, Arachidyl Glucoside, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Passiflora Edulis Fruit Extract, Ethylhexylglycerin, Glyceryl Oleate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Xanthan Gum, Cellulose Gum, Sodium Chloride, HippophaeRhamnoides Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Anthemis Nobilis Flower Oil, Cinnamomum Camphora Linalloliferum Wood Oil, Pelargonium Graveolens Flower Oil, Glucose, Parfum* (Fragrance), Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Rosmarinus Officinalis (Rosmary) Leaf Extract, Hydrogenated Palm Glycerides Citrate, Citric Acid, Sodium Hydroxide, Citronellol, Geraniol, Limonene, Linalool

*100% Natural Fragrance - Parfum 100% Naturel

Questions or comments?

please contact 800-437-3488 from 8:30-17:30 EST

Package Labeling: 51417-0003-1

Package Labeling: 51417-0002-5

INGREDIENTS AND APPEARANCE

REN CLEAN FAVOURITES 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51417-0003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51417-0003-1	1 in 1 KIT	09/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 mL

Part 1 of 1

CLEAN SCREEN MINERAL SPF30 MATTIFYING FACE SUNSCREEN BROAD SPECTRUM 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 51417-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
PROPANEDIOL (UNII: 5965N8W85T)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
STARCH, RICE (UNII: 4DGK8B7I3S)
KARUM SEED OIL (UNII: 62160PU6FJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DOCOSANOL (UNII: 9G1OE216XY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MANDARIN OIL (UNII: NJO720F72R)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51417-0002-1	1 in 1 BOX
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2019

Labeler - REN Ltd (385613831)