ADVANCED DYNAMICS SOOTHING DAY MOISTURE BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Advanced Dynamics Soothing day Moisture Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Advanced Dynamics Soothing 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 Ingredients       Purpose

Avobenzone 2.5%      Sunscreen

Octinoxate 6.5%        Sunscreen

Octisalate 4%            Sunscreen

Octocrylene 2.75%    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.

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, PEG-8 Beeswax/Cera Alba, Glyceryl Stearate, Dimethicone, Butyl Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Ceteth-20, Steareth-20, Sodium PCA, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Dimethicone Crosspolymer, Saccharide Isomerate, Hydrogenated Avocado Oil, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycyrrhiza Glabra (Licorice) Extract, Butylene Glycol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Avena Sativa (Oat) Kernel Extract Glycolipids, Soybean Phytosterols, Sodium Hyaluronate, Panthenol, Tocopheryl Acetate, Ethylhexylglycerin, Methylisothiazolinone, Trisodium EDTA, Cistus Incanus Extract, Maltodextrin

PRINCIPAL DISPLAY PANEL

Jafra Advanced Dynamics Soothing Day Moisture Broad Spectrum SPF 15

with Advanced Intellishield+

for sensitive skin

50 ml 1.7 FL OZ

INGREDIENTS AND APPEARANCE

ADVANCED DYNAMICS SOOTHING DAY MOISTURE BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-181
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.75 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
LICORICE (UNII: 61ZBX54883)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
OAT (UNII: Z6J799EAJK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE TRISODIUM (UNII: 420IP921MB)
CISTUS INCANUS FLOWERING TOP (UNII: N7Z341R6CA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-181-02	1 in 1 CARTON	11/26/2013
1	NDC: 68828-181-01	50 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 68828-181-04	1 in 1 CARTON	11/26/2013
2	NDC: 68828-181-03	7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 68828-181-06	1 in 1 CARTON	11/26/2013
3	NDC: 68828-181-05	2 mL in 1 PACKAGE; 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	11/26/2013

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(68828-181)