EMINENCE BRIGHT SKIN STARTER SET KIT- zinc oxide kit

Eminence Bright Skin Starter Set Kit by

Drug Labeling and Warnings

Eminence Bright Skin Starter Set Kit by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions

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 a 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
• 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: Sun Protection Measures 
• Limit time in the sun, especially from 10 a.m. - 2 p.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

Organic Phytonutrient Blend [Aloe Barbadensis (Aloe) Juice, Glycyrrhiza Glabra (Licorice) Root Extract*, Citrus Limon (Lemon) Peel Extract*, Cymbopogon Schoenanthus (Lemongrass) Extract*, Salix Alba (Willow) Bark Extract*, Arctostaphylos Uva Ursi (Bearberry) Leaf Extract*, Mentha Piperita (Peppermint) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Salvia Officinalis (Sage) Extract*, and Vegetable Glycerin], Persea Gratissima (Avocado) Oil*, Hypoxis Rooperi (African Potato) Extract, Vegetable Glycerin*, Aloe Barbadensis (Aloe) Juice*, Butyrospermum Parkii (Shea Butter)*, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Coco Caprylate/Caprate, Sempervivum Tectorum (Stone Crop) Extract*, Glyceryl Stearate, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Panthenol (Provitamin B5), Sodium Hyaluronate (Botanical Hyaluronic Acid), Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, Com-Derived Methyl Glucose Sesquistearate, Soy Lecithin, Polyhydroxystaric Acid, Xanthan Gum, Lactic Acid, Ascorbyl Palmitate (Vitamin C Ester), Citrus Limon (Lemon) Oil, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Chlorophyl, Sodium Benzoate, Potassium Sorbate, Sodium Phytate, Sodium PCA, Blocomplex2 (Euterpe Oleracea (Acai)*, Citrus Limon (Lemon)*, Malpighia Glabra (Barbados Cherry)*, Embica Officinalis (Indian Gooseberry)*, Adansonia Digitata (Baobab)*, Myrciaria Dubia (Camu Camu)*, Daucus Carota Sativa (Carrot)*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Berry*, Tapioca Starch (from Cassava Root)*, Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)]. *Certified organic ingredient

Note

Store in controlled temperatures (4–20°C/39–68°F). Keep in a dark and dry place. Keep container tightly closed. Do not use if seal under cap is broken or missing.

Package Labeling:Kit

Package Labeling:15751-3505-1

Non Drug Components

INGREDIENTS AND APPEARANCE

EMINENCE BRIGHT SKIN STARTER SET KIT 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-3504

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-3504-0	1 in 1 KIT	01/01/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	15 mL

Part 1 of 1

EMINENCE BRIGHT SKIN MOISTURIZER SPF 40 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 15751-3505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON (UNII: 24RS0A988O)
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
SALIX ALBA BARK (UNII: 205MXS71H7)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
ROSEMARY (UNII: IJ67X351P9)
SAGE (UNII: 065C5D077J)
GLYCERIN (UNII: PDC6A3C0OX)
AVOCADO OIL (UNII: 6VNO72PFC1)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
PRIMULA VERIS WHOLE (UNII: W6LFQ57E4M)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
PANTHENOL (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
LACTIC ACID (UNII: 33X04XA5AT)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SORBIC ACID (UNII: X045WJ989B)
CHLOROPHYLL (UNII: 00WNZ48OR9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ACAI (UNII: 46AM2VJ0AW)
CARROT (UNII: L56Z1JK48B)
COCONUT WATER (UNII: 267F5Y81NT)
STARCH, TAPIOCA (UNII: 24SC3U704I)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-3505-1	1 in 1 BOX
1		15 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 Drug	M020	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

Labeler - Eminence Organic Skin Care (205753317)