RECOVER SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA GOLD DYNAMICS- avobenzone, octinoxate, octisalate, oxybenzone cream

recover skin boosting moisturizer broad spectrum SPF 15 by

Drug Labeling and Warnings

recover skin boosting moisturizer broad spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Jafra Manufacturing. 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%                     Suncreen

PURPOSE

Uses

• helps prevent sunburn
• if used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused 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 Contro Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

• For external use only
• Do not use on damaged or broken skin
• Wehn using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscrren if swimmng 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, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:

     limit time in the sun, especially from 10 a.m. - 2 p.m.

     wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

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, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Castanea Sativa (Chestnut) Seed Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Saccharomyces/ Gold Ferment Lysate Filtrate, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceramide 2, PEG 10 Brassica Campestris Sterol, Palmitoyl Hexapeptide-12, C12-15 Alkyl Benzoate, Tribehenin, Triethanolamine, Panthenol, Citronellol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Glycine Soja (Soybean) Isoflavone Aglyone, Lecithin, Polysorbate 80, Alcohol, Tocopheryl Acetate, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Smithsonite Extract, Citonellol, Limonene, Linalool

PRINCIPAL DISPLAY PANEL

Jafra

Gold dynamics recover

Skin boosting moisturizer broad spectrum SPF 15

50 ml    1.7 FL OZ.

INGREDIENTS AND APPEARANCE

RECOVER SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA GOLD DYNAMICS
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 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 (40 CST) (UNII: 343C7U75XW)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
PAPAYA (UNII: KU94FIY6JB)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CERAMIDE 2 (UNII: C04977SRJ5)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TROLAMINE (UNII: 9O3K93S3TK)
PANTHENOL (UNII: WV9CM0O67Z)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-202-02	1 in 1 PACKAGE	12/01/2014
1	NDC: 68828-202-01	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 final	part352	12/01/2014

Labeler - Jafra Cosmetics International (041676479)

Registrant - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing		814732061	manufacture(68828-202)