DAY MOISTURIZER SPF 15- octocrylene butyl methoxydibenzoyl methane (avobenzone) cream 
PF Invest Company

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.

----------

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

LABEL

DAY MOISTURIZER SPF 15 
octocrylene butyl methoxydibenzoyl methane (avobenzone) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61220-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61220-002-0250 mg in 1 JAR; Type 0: Not a Combination Product03/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/11/2016
Labeler - PF Invest Company (079180054)
Establishment
NameAddressID/FEIBusiness Operations
E.L. Erman Cosmetic Manufacturing Ltd.531894152manufacture(61220-002)

Revised: 3/2016
Document Id: 2e0769a3-6eb9-0eef-e054-00144ff88e88
Set id: 2dcbd1f2-da6e-517a-e054-00144ff8d46c
Version: 4
Effective Time: 20160311
 
PF Invest Company