FIRMING AND MOISTURIZING BODY- octinoxate emulsion

FIRMING AND MOISTURIZING by

Drug Labeling and Warnings

FIRMING AND MOISTURIZING by is a Otc medication manufactured, distributed, or labeled by Zenith Medicosm SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%

Description

SUN CARE CREAM FOR BODY

SPF 25

MEDIUM PROTECTION

UVA - UVB - WATER RESISTANT

Body emulsion rich in anti-age ingredients.  Its formula protects skin from UVB and UVA rays while moisturizing and reaffirming the skin (collagen, aloe vera, green tea).  Easy o apply for even, translucent coverage. Water resistant.

150ml. 5Fl.Oz.

Warning

TOPICAL USE / PROFESSIONAL ONLY

Instructions for use

Apply a considerable amount on entire body every day, with special emphasis on dry and damaged areas (legs, elbows, knees). Massage gently into the skin until completely absorbed

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRMING AND MOISTURIZING  BODY
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42248-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	18.75 mL  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-6 STEARATE (UNII: 8LQC57C6B0)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
SOYBEAN (UNII: L7HT8F1ZOD)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PEG-32 STEARATE (UNII: 33GX5WQC0M)
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)
OLIVE OIL (UNII: 6UYK2W1W1E)
EDETIC ACID (UNII: 9G34HU7RV0)
DIMETHICONE (UNII: 92RU3N3Y1O)
CUCUMBER (UNII: YY7C30VXJT)
UREA (UNII: 8W8T17847W)
ARNICA MONTANA (UNII: O80TY208ZW)
IMIDUREA (UNII: M629807ATL)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
FISH SKIN COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42248-132-01	250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/15/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

Establishment
Name	Address	ID/FEI	Business Operations
Zenith Medicosm SL		464239694	manufacture