EMINENCE TROPICAL VANILLA DAY CREAM SPF 40 SUNSCREEN- zinc oxide cream 
Eminence Organic Skin Care

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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Eminence Tropical Vanilla Day Cream SPF 40 Sunscreen

Drug Facts

Active Ingredients

Zinc Oxide 20%

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 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 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
  • 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. - 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 Blen [Tila Cordata (Linden) Flower Tea*, Aloe Barbadensis (Aloe) Juice, Camellia Sinensis (Green Tea) Leaf Extract*, Vanilla Planifolia (Vanilla) seed Extract* and Soy Lecithin*), Persea Gratissima (Avocado) Oil*, Vegetable Glycerin*, Aqua (Water), ALoe Barbadensis (Aloe) Juice*, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Coco Caprylate/Caprate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter)*, Panthenol (Provitamin B5), Sodium Hyaluronate (Botanical Hyaluronic Acid), Sodium PCA, Dehydroacetic Acid, Benzyl Alcohol, Acacia Senegal (Acacia) Gum, Corn-Derived Methyl Glucose sesquistearate, Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, L-Proline, Hydroxyproline, Polyhydroxystearic Acid, Ascorbyl Palmitate (Vitamin C Ester), Triheptanoin c13-15 Alkane, Soy Lecithin, Lactic Acid, Sodium Phytate, Aromatic Vanilla Essence, Blocomplex2 [Euterpe Oleracea (Acai)*, Citrus Limon (Lemon)*, Malpighia Glabra (Barbados Cherry)*, Emblica 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:60 ml

Outer Package.3Inner Package.3

Package Labeling:125 ml

Outer Package4Inner Package4

EMINENCE TROPICAL VANILLA DAY CREAM SPF 40 SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
VANILLA BEAN (UNII: Q74T35078H)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ACACIA (UNII: 5C5403N26O)  
PROLINE (UNII: 9DLQ4CIU6V)  
HYDROXYPROLINE (UNII: RMB44WO89X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LACTIC ACID (UNII: 33X04XA5AT)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
LEMON (UNII: 24RS0A988O)  
CARROT (UNII: L56Z1JK48B)  
COCONUT WATER (UNII: 267F5Y81NT)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
THIOCTIC ACID (UNII: 73Y7P0K73Y)  
UBIDECARENONE (UNII: EJ27X76M46)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15751-3500-11 in 1 BOX01/01/2021
160 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:15751-3500-21 in 1 BOX01/01/2021
2125 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2021
Labeler - Eminence Organic Skin Care (205753317)

Revised: 12/2020
 
Eminence Organic Skin Care