LILIKOI MINERAL DEFENSE MOISTURIZER SPF 33- titanium dioxide, zinc oxide cream

Lilikoi Mineral Defense Moisturizer SPF 33 by

Drug Labeling and Warnings

Lilikoi Mineral Defense Moisturizer SPF 33 by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 7.8%

Zinc Oxide 4%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of 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 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 Blend [(Tilia Cordata (Linden) Flower Tea, Aloe Barbadensis (Aloe) Juice, Camellia Sinensis (Green Tea) Leaf Extract, Vanilla Planifolia (Vanilla) Seed Extract and Soy Lecithin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Vitis Vinifera (Grape) Seed Oil, Glyceryl Stearate, Persea Gratissima (Avocado) Oil, Vegetable Glycerin, Galactoarabinan (from Larch Tree), Corn-Derived Methyl Glucose Sesquistearate, Aloe Barbadensis (Aloe Vera) Juice, Botanical Hyaluronic Acid, Tocopheryl Acetate (Vitamin E), Panthenol (Provitamin B5), Propanediol, Citrus Unshiu (Satsuma Mandarin) Peel Extract, Benzyl Alcohol, Salicylic Acid, Carica Papaya (Papaya) Fruit Extract, Passiflora Edulis (Passion Fruit) Seed Oil, Ginkgo Biloba Leaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Matricaria Recutita (Chamomile) Extract, Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, Caesalpinia Spinosa (Tara Tree) Gum, Brassica Campestris (Rapeseed)/Aleurites Fordii (Tung Tree) Oil Copolymer, Xanthan Gum, Hippophae Rhamnoides (Seabuckthorn) Fruit Oil, Magnesium Ascorbyl Phosphate, Sorbic Acid, Lecithin, Trisodium EDTA, Biocomplex2 (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)].
*Cerified 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.

Lilikoi Mineral Defense Moisturizer SPF 33, 2 fl. oz. (

15751-3333-2)

Lilikoi Mineral Defense Moisturizer SPF 33, 4.2 fl. oz. 15751-3333-4

INGREDIENTS AND APPEARANCE

LILIKOI MINERAL DEFENSE MOISTURIZER SPF 33 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-3333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
VANILLA (UNII: Q74T35078H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AVOCADO OIL (UNII: 6VNO72PFC1)
GALACTOARABINAN (UNII: SL4SX1O487)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
PROPANEDIOL (UNII: 5965N8W85T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PAPAYA (UNII: KU94FIY6JB)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
GINKGO (UNII: 19FUJ2C58T)
CHAMOMILE (UNII: FGL3685T2X)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
XANTHAN GUM (UNII: TTV12P4NEE)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
SORBIC ACID (UNII: X045WJ989B)
EDETATE TRISODIUM (UNII: 420IP921MB)
ACAI (UNII: 46AM2VJ0AW)
LEMON (UNII: 24RS0A988O)
CARROT (UNII: L56Z1JK48B)
COCONUT (UNII: 3RT3536DHY)
WATER (UNII: 059QF0KO0R)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-3333-2	1 in 1 BOX	03/01/2019
1		60 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 15751-3333-4	1 in 1 BOX	03/01/2019
2		125 mL in 1 JAR; 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	03/01/2019

Labeler - Eminence Organic Skin Care Ltd. (205753317)