ACTIVE RADIANCE DAY MOISTURE SPF 30- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Active Radiance Day Moisture SPF 30 by

Drug Labeling and Warnings

Active Radiance Day Moisture SPF 30 by is a Otc medication manufactured, distributed, or labeled by COSMETIC ENTERPRISES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredients                         Purpose

Avobenzone 3.0% ........................ Sunscreen

Octinoxate 5.0% ........................... Sunscreen

Octisalate 5.0% ............................ Sunscreen

Octocrylene 2.4% ......................... Sunscreen

Oxybenzone 5.0% ........................ Sunscreen

PURPOSE

​Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (​see Directions​), decreases the risk of skin Cancer and early skin aging cause by the sun 

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 

INDICATIONS & USAGE

​Stop use and ask a doctor if ​- rash occurs

WARNINGS

​Warnings

• ​For exter use only
• ​Do not use ​on damaged or broken skin
• when usign this porduct ​keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

​Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours and after towel drying, swimming, or perspiring to avoid lowering sun protection
• ​Sun Protection Measures ​UV exposure from the sun increase to the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time spent in the sun from 10 a.m. - 2 p.m. and wearing protective clothing
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Water (Aqua), Caprylyl Methicone, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol, Glycerin, Steareth-21, Mica, Cetearyl Alcohol, Ethylhexyl Methoxycrylene, Titanium Dioxide, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Phyllanthus Emblica Fruit Extract, Phospholipids, Linoleic Acid, Arachidly Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Cetearyl Glucoside, Boron Nitride, Aluminum Starch Octenylsuccinate, Xanthan Gum, Polyacrylate-13, Polyisobutene, Polysorbate 20, Phenoxyethanol, Chlorphenesin, Pentaerythrityl Tetra-Di-t-Buty Hydroxyhydrocinnamate, Disodium EDTA

PRINCIPAL DISPLAY PANEL

Specific Beauty

Active Radiance

Day Moisture

Broad Spectrum SPF 30

1.7 FL. OZ. / 50 mL

INGREDIENTS AND APPEARANCE

ACTIVE RADIANCE DAY MOISTURE SPF 30 
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
STEARETH-21 (UNII: 53J3F32P58)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
BORON NITRIDE (UNII: 2U4T60A6YD)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5004-2	1 in 1 BOX	03/01/2017
1	NDC: 56152-5004-1	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2017

Labeler - COSMETIC ENTERPRISES LTD (017701475)

Registrant - COSMETIC ENTERPRISES LTD (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC ENTERPRISES LTD		017701475	manufacture(56152-5004)