LAVENDER PROTECTIVE MOISTURIZER SPF 17- zinc oxide lotion

Lavender Protective Moisturizer SPF 17 by

Drug Labeling and Warnings

Lavender Protective Moisturizer SPF 17 by is a Otc medication manufactured, distributed, or labeled by Naturopathica Holistic Health, Inc., Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 7.02%

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 signs of aging caused by the sun

Warning

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Aqua (Water), Caprylic/ Capric Triglyceride, Cetearyl Olivate, Glycerin, Cyclopentasiloxane, Sorbitan olivate, Squalane, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Xanthan Gum, Magnesium Aluminum Silicate, Simmondsia Chinensis (Jojoba) Seed Oil, 12-Hexanediol, Glyceryl lsostearate, Caprylyl Glycol, Alcohol Denat., Citric Acid, Leuconostoc/Radish Root Ferment Filtrate, Populus Tremuloides Bark Extract, Lavandula Angustifolia (Lavender) Oil, Tocopheryl Acetate (D-alpha), Polyhydroxystearic Acid, Beta-Glucan (D), Gluconolactone, Phytic Acid, Potassium Sorbate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Cinnamomum Camphora (Camphor) Bark Oil, Tropolone, Elaeis Guineensis (Palm) oil, Tocotrienols, Tocopherol (D-alpha), Tetrahydrodiferuloylmethane, Astaxanthin, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrobisdemethoxydiferuloylmethane, Hamamelis Virginiana (Witch Hazel) Water, Alcohol,

Other information

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

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use 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 the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit lime in sun, especially between 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6, ask a doctor

Lavender Protective Moisturizer SPF 17

INGREDIENTS AND APPEARANCE

LAVENDER PROTECTIVE MOISTURIZER SPF 17 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64657-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE (UNII: 44D8X9U00T)
FYTIC ACID (UNII: 7IGF0S7R8I)
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
WHEAT GERM OIL (UNII: 14C97E680P)
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
XANTHAN GUM (UNII: TTV12P4NEE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
ASTAXANTHIN (UNII: 8XPW32PR7I)
HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
CAMPHOR OIL (UNII: 75IZZ8Y727)
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I)
ALCOHOL (UNII: 3K9958V90M)
PALM OIL (UNII: 5QUO05548Z)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64657-006-05	65 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2017

Labeler - Naturopathica Holistic Health, Inc. (104302175)

Establishment
Name	Address	ID/FEI	Business Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories		959735002	manufacture(64657-006)