DAY MOISTURIZER SPF 15 (octocrylene butyl methoxydibenzoyl methane- avobenzone cream

Day Moisturizer SPF 15 by

Drug Labeling and Warnings

Day Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by E.L. Erman Cosmetic Manufacturing Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Octocrylene 5%

Avobenzone (Butyl Methoxydibenzoyl Methane) 3%

PURPOSE

Sunscreen

INDICATIONS AND USAGE

Moisturizer cream provides deep hydration with UV protection for a beautiful, youth-inspired complexion

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE AND ADMINISTRATION

Directions
Apply an even amount of cream onto dry, cleansed skin.
Gently massage in with your fingertips until fully absorbed.

WARNINGS

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging
For external use only
Do not use on damaged or broken skin
When using this product keер out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.

INACTIVE INGREDIENTS

Olea Europaea (Olive) Fruit Oil, Cetearyl Alcohol, Cetyl Alcohol, Glycerin, Vitis Vinifera (Grape) Seed Oil,
Cera Alba (Beeswax), Aloe Barbadensis Leaf Juice, Phenoxyethanol, Maris Aqua (Dead Sea Water), Borago Officinalis (Borage)
Seed Oil, Gluconolactone, Water Glycerin Macrocystis Pyrifera Extract Hydrolyzed Wheat Protein PVP, Dimethicone,
Sodium Benzoate, Butyrospermum Parkii (Shea Butter), Calendula Officinalis Flower Oil, Anthemis Nobilis (Chamomile)
Flower Extract, Fragrance (Parfum) , Stearic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Triethylene Glycol, Allantoin,
Oenothera Biennis (Evening Primrose) Oil, Rosa Canina Fruit Oil, Algae Extract, Camellia Sinensis Leaf Extract,
Macadamia Ternifolia Oil, Tocopheryl Acetate (Vit. E), Hyaluronic Acid, NIAPEPTYGOLD (NIACINAMIDE (VITAMIN B3) WATER
PALMITOYL HEXAPEPTIDE-9 PHENOXYETHANOL UBIQUINONE LEPIDIUM SATIVUM SPROUT EXTRACT CI 77480 (GOLD 24K)).

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

DAY MOISTURIZER SPF 15 
octocrylene butyl methoxydibenzoyl methane (avobenzone) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43638-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALLANTOIN (UNII: 344S277G0Z)
CAMELLIA SINENSIS SEED (UNII: MRL49Z8AC4)
MACADAMIA OIL (UNII: 515610SU8C)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
DIMETHICONE 100 (UNII: RO266O364U)
JOJOBA ACID (UNII: MO7HV04S9Y)
CETEARYL PHOSPHATE (UNII: 4O6GCK4CTJ)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
PALMITOYL FRAGMENT (UNII: 2V59YXW6GO)
VITIS VINIFERA LEAF OIL (UNII: 76K69S9H5Z)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
GLYCERIN (UNII: PDC6A3C0OX)
LEPIDIUM SATIVUM SEED (UNII: WZM06UL78H)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BETULA PAPYRIFERA WHOLE (UNII: SL7A75J492)
OENOTHERA BIENNIS (UNII: 76UI55V071)
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
SHEA BUTTER (UNII: K49155WL9Y)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CHAMOMILE (UNII: FGL3685T2X)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43638-002-04	50 mg in 1 JAR; Type 0: Not a Combination Product	03/18/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/14/2016

Labeler - E.L. Erman Cosmetic Manufacturing Ltd. (531894152)

Establishment
Name	Address	ID/FEI	Business Operations
E.L. Erman Cosmetic Manufacturing Ltd.		531894152	manufacture(43638-002)