OIL-FREE FACIAL SUNSCREEN SPECTRUM SPF 50 JAFRA- avobenzone, homosalate, octisalate, octocrylene lotion

Oil-Free Facial Sunscreen Spectrum SPF 50 by

Drug Labeling and Warnings

Oil-Free Facial Sunscreen Spectrum SPF 50 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 3.0% ........  Sunscreen

Homosalate  10% ......... Sunscreen

Octisalate     5%  .......... Sunscreen

Octocrylene  7%  .......... Sunscreen

SPL UNCLASSIFIED SECTION

PURPOSE

• 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

Warning

For external use only

Do not use on damaged or broken skin

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

DOSAGE & ADMINISTRATION

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 the risk, regularly use sunscreen with a Broad Sectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10a.m. - 2p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients

Water/Aqua, Glyceryl Stearate, PEG- 100 Stearate, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Ehtylhexylglycerin, Cyclopentasiloxane, Acylates/Dimethicone Copolymer, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Bisabolol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Disodium EDTA, Panthenol, Allantoin, Tocopheryl Acetate, Chlorphenesin, Thermus Thermophillus Ferment, Ipomoea Batatas Tuber Extract, Withania Somniferia (Winter Cherry) Extract, Vigna Radiata (Mug Bean) Extract, Ethylhexylglycerin, Methylisothiazolinone  

PRINCIPAL DISPLAY PANEL

JAFRA

SUN

Oil-Free Facial Sunscreen Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

OIL-FREE FACIAL SUNSCREEN SPECTRUM SPF 50  JAFRA
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-215
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	10 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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
LAUROYL LYSINE (UNII: 113171Q70B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ARGININE (UNII: 94ZLA3W45F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
SWEET POTATO (UNII: M9WGG9Z9GK)
MUNG BEAN (UNII: 1LIB31N73G)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-215-02	1 in 1 CARTON	02/13/2015
1	NDC: 68828-215-01	50 mL in 1 TUBE; 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	02/13/2015

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(68828-215)