BALANCING DAY MOISTURE BROAD SPECTRUM SPF 15 JAFRA- avobenzone,octinoxate, octisalate, octisalate, oxybenzone cream

Balancing Day Moisture Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Balancing Day Moisture Broad Spectrum SPF 15 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 ingredient         Purpose

Avobenzone  2.75%    Sunscreen

Octinoxate 7.5%          Sunscreen

Octisalate 5%              Sunscreen

Oxybenzone 2%          Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and 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, 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 Ingredients

Water/Aqua, C14-20 Alcohols, C12-20 Alkyl Glucoside, Glyceryl Stearate, Ipomoea Batatas Tuber Extract, Centella Asiatica, Withania Somnifera Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyltaurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane, Coconut Ether, Saccharide Isomerate, Biosaccharide Gum, Castanea Sativa (Chestnut) Seed Extract, Fragrance/parfum,  Propylene Glycol, Laminaria Saccharina Extract, DMDM Hydantoin, Biosaccharide Gum-4, Chondrus Chrispus (Carrageenan) Extract, Panthenol, Tocopherol, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Cistus Incanus Extract, Maltodextrin, Trisodium EDTA,  Lysine Carboxymethyl Cysteinate, Lysine Thiazolidine Carboxylate

PRINCIPAL DISPLAY PANEL

Jafra Advanced Dynamics balancing

day moisture broad spectrum SPF 15

with Advanced Intellishield+

for normal/combination skin

50ml 1.7 FL OZ

INGREDIENTS AND APPEARANCE

BALANCING DAY MOISTURE BROAD SPECTRUM SPF 15  JAFRA
avobenzone,octinoxate, octisalate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.75 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SWEET POTATO (UNII: M9WGG9Z9GK)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CISTUS INCANUS FLOWERING TOP (UNII: N7Z341R6CA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EDETATE TRISODIUM (UNII: 420IP921MB)
CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)
LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-182-02	1 in 1 CARTON	10/28/2013
1	NDC: 68828-182-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68828-182-04	1 in 1 CARTON	10/28/2013
2	NDC: 68828-182-03	7.5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68828-182-06	1 in 1 CARTON	10/28/2013
3	NDC: 68828-182-05	2 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	10/28/2013

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(68828-182)