Label: DAY MOISTURIZER SPF 15 (octocrylene butyl methoxydibenzoyl methane- avobenzone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 61220-002-02 - Packager: PF Invest Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 11, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- INDICATIONS AND USAGE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE AND ADMINISTRATION
-
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) creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61220-002 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:61220-002-02 50 mg in 1 JAR; Type 0: Not a Combination Product 03/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/11/2016 Labeler - PF Invest Company (079180054) Establishment Name Address ID/FEI Business Operations E.L. Erman Cosmetic Manufacturing Ltd. 531894152 manufacture(61220-002)
