HYDRATING DAY MOISTURE BROAD SPECTRUM SPF15 JAFRA- avobenzone, octinoxate, octisalate, oxybenzone cream

Hydrating day moisture broad spectrum SPF15 by

Drug Labeling and Warnings

Hydrating day moisture broad spectrum SPF15 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  2.5%     Sunscreen

Octinoxate 6.5%         Sunscreen

Octisalate 4%             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 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.
 Stop use and ask a doctor if rash occurs

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

Water/Aqua, Caprylic/Capric Triglyceride, Dimethicone, PEG-8, Beeswax/Cera Alba, Glyceryl Stearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Cetyl Alcohol, Ceteareth-20, Steareth-20, Hemidesmus Indicus Extract, Glycyrrhiza Glabra (Licorice) Extract, Withania Somnifera Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter) Fruit, Sodium PCA, Hydrogenated Avocado Oil, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Dimethicone, Dimethicone Crosspolymer, Methylsilanol  Manuuronate, Saccharide Isomerate, Glycolipids, Soybean Phytosterols, Sodium Hyaluronate, Secale Cereale (Rye) Seed Extract, Fragrance, Biosaccharide-4, Chondrus Crispus (Carrageenan) Extract, Panthenol, Tocopheryl Acetate, Trisodium EDTA, Cistus Incanus Extract,  Maltodextrin, Ethylhexylglycerin, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL

Jafra

advanced dynamics hydrating

day moisture broad spectrum SPF 15

with Advanced Intellishield

for dry skin

50 ml 1.7 FL OZ

INGREDIENTS AND APPEARANCE

HYDRATING DAY MOISTURE BROAD SPECTRUM SPF15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-179
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	6.5 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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
LICORICE (UNII: 61ZBX54883)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
CISTUS INCANUS FLOWERING TOP (UNII: N7Z341R6CA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-179-02	1 in 1 CARTON	11/25/2013
1	NDC: 68828-179-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68828-179-04	1 in 1 CARTON	11/25/2013
2	NDC: 68828-179-03	7.5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68828-179-06	1 in 1 CARTON	11/25/2013
3	NDC: 68828-179-05	2 mL in 1 POUCH; 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	11/25/2013

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(68828-179)