SUN PROTECTION BODY- avobenzone, homosalate, octislate, oxybenzone lotion

Sun protection body by

Drug Labeling and Warnings

Sun protection body by is a Otc medication manufactured, distributed, or labeled by Juvena Produits de Beaute GMBH, Temmentec Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients          Purpose   

 Avobenzone 3.0%         sunscreen

Homosalate 7.0%            sunscreen

Octisalate 5.0 %            sunscreen

oxybenzone 5.0 %         sunscreen

Keep out of reach of children
Do not use on infants under 6 months of age.

Stop use and ask a doctor if rash or irritation develops and lasts.

when using this product keep out of eyes. Rinse with water to remove.

- Apply daily after cleansing and toning

-smooth over body

-apply evenly before sun exposure

-reapply as needed or after towel drying, swimming or perspiring

Water ( Aqua), Butyloctyl Salicaylate, Undecrylene Dimethicon, Polyester-8, Caprylyl Methicone, Polyglyceryl-3 Methylglucose Distearate, Octyldodecyl Olivate, Pentylene Glycol, Steareth-21, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Allantoin, Porphyras Umbilicalis Extract, Tocopheryl Acetate, Benzylidene Dimethoxydimethylindanone, Sea Water ( Maris Aqua) Diethylhexy Syringyldenemalonate, Polyacrylamide, Potassium Sorbate, Xanthan Gum , Pelvetia Canaliculate Extract, Lecithin, Caprylic/ Capric Triglyceride, Palmmaria Palmate Extract, Ethylhexyl Glycerin, Algae Extract, Steareth-2, Disodium EDTA, Hydroxypropyl Starch Phosphate, Alcohol. C13-14 Isoparaffin, Sodium Lactate, Cetyl Alcohol, Dipropylene Glycol, Laureth-7, Fragrance ( Parfum), Benzyl Alcohol, Sodium Benzoate, Phenoxyethanol, Chlorphenesin, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

Sun Protection lotion body SPF 30

180mL/ 6.0 FL.OZ

INGREDIENTS AND APPEARANCE

SUN PROTECTION BODY   SPF 30
avobenzone, homosalate, octislate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59614-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LAURETH-7 (UNII: Z95S6G8201)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59614-511-02	1 in 1 BOX
1	NDC: 59614-511-01	180 mL in 1 BOTTLE
2	NDC: 59614-511-11	0.09 mL in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/14/2011

Labeler - Juvena Produits de Beaute GMBH (315053785)

Registrant - Temmentec Ag (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture