JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs by

Drug Labeling and Warnings

Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker,LLC, Paklab (AKA Diversapak of California/Universal Packaging Sysytem, Inc), Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact Label

Active ingredient

Avobenzone - 2.0%
Homosalate - 10.0%
Octisalate - 5.0%
Octocrylene - 1.3%
Oxybenzone - 4.0%

Purpose

Sunscreen

Use

• Helps prevents 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.

Warnings

For external use only

• Do not use on damaged or broken skin.

• Stop use and ask a doctor if rash occurs

• When using this product keep out of eye. Rinse with water to remove.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • - Limit time in the sun, especially from 10 a.m.-2p.m.
  • - Wear long-sleeved shirts, pants, hats and sunglasses.

Other information

• Protect the product in this container from excessive heat and direct sunlight.

Inactive ingredients

Water, Glycolic Acid, Glycerin, Steareth-20, PEG-100 Stearate, Hexyl Laurate, Dimethicone, Cetyl Alcohol, Steareth-2, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Hydroxide, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Ormenis Multicaulis Oil, Panthenol, Allantoin, Butylene Glycol, Bentonite, Glyceryl Stearate, Hydrogenated Palm Glycerides, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin

Questions or comments?

1-877-435-7383

PRINCIPAL DISPLAY PANEL - Tube Label

AM

All Day Moisture
with AHAs
SPF 15
Broad Spectrum
Sunscreen

Active
Ingredients
Avobenzone 2.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 1.3%
Oxybenzone 4.0%

M050597

Peel here for
Drug Facts
Information

INGREDIENTS AND APPEARANCE

JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2 mg  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	1.3 mg  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycolic Acid (UNII: 0WT12SX38S)
Glycerin (UNII: PDC6A3C0OX)
AMMONIA (UNII: 5138Q19F1X)
Steareth-20 (UNII: L0Q8IK9E08)
PEG-100 Stearate (UNII: YD01N1999R)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Dimethicone (UNII: 92RU3N3Y1O)
Steareth-2 (UNII: V56DFE46J5)
Cetyl Alcohol (UNII: 936JST6JCN)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Allantoin (UNII: 344S277G0Z)
Panthenol (UNII: WV9CM0O67Z)
Butylene Glycol (UNII: 3XUS85K0RA)
Propylene Glycol (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Stearic Acid (UNII: 4ELV7Z65AP)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Xanthan Gum (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-026-13	50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/30/2017
2	NDC: 70605-026-57	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/30/2017
3	NDC: 70605-026-11	30 mL in 1 TUBE; Type 0: Not a Combination Product	12/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/30/2017

Labeler - Guthy-Renker,LLC (948861877)

Establishment
Name	Address	ID/FEI	Business Operations
Paklab (AKA Diversapak of California/Universal Packaging Sysytem, Inc)		790530976	MANUFACTURE(70605-026)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(70605-026)