FACE LIFT BROAD SPECTRUM SPF 20 JAFRA PRO- avobenzone, homosalate, octisalate, octocrylene lotion

Face Lift Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Face Lift Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 7% 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 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 Control 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
When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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 broad spectrum SPF of 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, Butylene Glycol, Sorbitan Laurate, Hydroxyethylcellulose, Acetyl Dipeptide-1, Cetyl Ester, Pentylene Glycol, Cetearyl Alcohol, Coco-glucoside, Algae Extract, Pullulan, Niacinamide, Hydrolyzed Soy Protein, Zea Mays (Corn) Kernel Extract, Xanthan Gum, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Glycerin, Avena Sativa (Oat) Kernel Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Santalum Album (Sandalwood) Wood Extract, Rose Extract, Pyrus Malus, Hydrolyzed Soy Protein, Zea (Apple) Fruit Extract, Passiflora Incarnata Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Cananga Odorata Flower Extract, Cucumis Melo Cantalupensis Fruit Extract, C20-22 Alkyl Phosphate, C20-22 Alcohols, Caprylic/Capric Triglyceride, Alaria Esculenta Extract, Yeast Amino Acids, Tricalcium Phosphate, Morinda Citrifolia Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Pichia Anomala Extract, Tripleurospermum Maritima Extract, Microcrystalline Cellulose, Cellulose Gum, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Oil, Arnica Montana Flower Extract, Tocopheryl, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butlcarbamate, Menthyl Lactate, Benzylidene Dimethoxydimethylindanone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7.

PRINCIPAL DISPLAY PANEL

Jafra Pro
Face Lift Broad Spectrum SPF 20
Cont. Net. 30 ml 1 Fl Oz

INGREDIENTS AND APPEARANCE

FACE LIFT BROAD SPECTRUM SPF 20  JAFRA PRO
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-133
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
N-ACETYL DIPEPTIDE-1 (UNII: HA41Z1UF8D)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
PULLULAN (UNII: 8ZQ0AYU1TT)
NIACINAMIDE (UNII: 25X51I8RD4)
CORN (UNII: 0N8672707O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
UREA (UNII: 8W8T17847W)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)
COCONUT OIL (UNII: Q9L0O73W7L)
CUCUMBER (UNII: YY7C30VXJT)
SANDALWOOD (UNII: 3641YW25N2)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
APRICOT (UNII: 269CJD5GZ9)
RASPBERRY (UNII: 4N14V5R27W)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
CANTALOUPE (UNII: 8QF5D5H6UH)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)
PAPAYA (UNII: KU94FIY6JB)
LICORICE (UNII: 61ZBX54883)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-133-02	1 in 1 CARTON	04/15/2013
1	NDC: 68828-133-01	30 mL in 1 BOTTLE; 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	04/15/2013

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-133)