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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Jafra Soothing Day Moisture Broad Spectrum SPF 15

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

carton

Jafra Advanced Dynamics Soothing Day Moisture Broad Spectrum SPF 15

with Advanced Intellishield+

for sensitive skin

50 ml 1.7 FL OZ

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-181-02	1 in 1 CARTON	11/26/2013	01/01/2021
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	01/01/2021
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	01/01/2021
3	NDC:68828-181-05	2 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/26/2013	01/01/2021

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-181)

Revised: 1/2021

Document Id: b8a8f628-94c9-9509-e053-2a95a90a683b

Set id: d4f54fae-76a3-4203-b787-719f81dbcd39

Version: 3

Effective Time: 20210111

Jafra Cosmetics International Inc