FACIAL BOOSTING BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, oxybenzone cream

Facial Boosting Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Facial Boosting Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 2.5% Sunscreen

Octinoxate 7.5 % Sunscreen

Octisalate 4 % Sunscreen

Oxybenzone 2% Sunscreen

Uses

helps prevents sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To Decrease this risk

Inactive Ingredients
Water/Aqua, Cetearyl Alcohol, Ceteareth-20, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Cyclomethicone, Dimethiconol, Bis-Diglyceryl Polyacyladipate-2, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Castanea Sativa (Chestnut) Seed Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ceramide 2, PEG 10 Brassica Campestris Sterol, Palmitoyl Oligopeptide, C12-15 Alkyl Benzoate, Tribehenin, Glycyrrhiza Glabra (Licorice) Extract, Moringa Oliefera Extract, Vetivera Zinzanoids (Khus Root) Extract, Withania Somnifera (Winter Cherry) Extract, Tocopherol, Fragrance/parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Panthenol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Glycine Soja (Soybean) Isoflavone Aglycone, Lecithin, Polysorbate 80, Mentha Piperita (peppermint) Extract, Alcohol, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate.

PRINCIPAL DISPLAY PANEL

Jafra

Harmony Dynamics

Facial Boosting Cream Broad Spectrum SPF 15

with intellishield

Cont. Net. 50 ml 1.7 Fl Oz.

INGREDIENTS AND APPEARANCE

FACIAL BOOSTING BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CERAMIDE 2 (UNII: C04977SRJ5)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
LICORICE (UNII: 61ZBX54883)
TOCOPHEROL (UNII: R0ZB2556P8)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
PANTHENOL (UNII: WV9CM0O67Z)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-159-02	1 in 1 CARTON	11/30/2012
1	NDC: 68828-159-01	50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/30/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-159)