Jane Seymour Oil-Free Tinted Moisturizer with SPF 55 by Guthy-Renker, LLC. / AMCOL Health & Beauty Solutions, Incorporated / Thibiant, International, Inc.

Jane Seymour Oil-Free Tinted Moisturizer with SPF 55 by

Drug Labeling and Warnings

Jane Seymour Oil-Free Tinted Moisturizer with SPF 55 by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker, LLC., AMCOL Health & Beauty Solutions, Incorporated, Thibiant, International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JANE SEYMOUR OIL-FREE TINTED MOISTURIZER WITH SPF 55- oxybenzone, octocrylene, octisalate, avobenzone, homosalate liquid 
THE PROACTIV COMPANY LLC

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.

----------

DIRECTIONS:

Apply to face every morning after cleansing.

ACTIVE INGREDIENTS:

Oxybenzone 6.0%, Octocrylene 2.0%, Octisalate 5.0%, Avobenzone 3.0%, Homosalate 10.0%

INACTIVE INGREDIENTS:

Water, Butylene Glycol, PEG-8, Poly-Ethylene, Silica, Dimethicone, Picea Excelsa Wood Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Methyl Glucose Sesquistearate, Glycerin, Acrylates/C10-30 Alkyl Acrylates Cross-Polymer, Bentonite, Sodium Hydroxide, Sodium Polyacrylate, Disodium EDTA, Xanthan Gum, Ammonium Poly-Acrylate, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin, Alumina, Iron oxides (C.I. 77492), Titanium Dioxide, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77499)

Distributed by: Guthy-Renker®, LLC
P.O. Box 14383
Palm Desert, CA 92255-4383
London UK SW1Y 4HH,
Sydney, Australia 2138,
Auckland, New Zealand,
Toronto, Ontario M1X 1E7

M050903
ND.0076

Principal Display Panel – 30 mL Tube

Natural

Advantage®

Jane Seymour

Oil-Free

Tinted

Moisturizer

With SPF 55

1 fl oz 30 ml e

JANE SEYMOUR OIL-FREE TINTED MOISTURIZER WITH SPF 55 
oxybenzone, octocrylene, octisalate, avobenzone, homosalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	20 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PICEA ABIES WOOD (UNII: 72GZ8K8996)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)
BENTONITE (UNII: A3N5ZCN45C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-412-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2011	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/04/2011	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Incorporated		872684803	manufacture(11410-412)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant, International, Inc.		083913913	manufacture(11410-412)

Revised: 1/2020

Document Id: f23f4d72-bf78-42d8-8852-826879da4eca

34390-5

Set id: ec8411f0-c6cb-4631-a470-20a0fb50241e

Version: 2

Effective Time: 20200114

 

THE PROACTIV COMPANY LLC