SPF 30 with Retinol by AMCOL Health & Beauty Solutions, Inc. / AMCOL Health & Beauty Solutions, Inc DBA AMCOLHousehold and Personal Care

SPF 30 with Retinol by

Drug Labeling and Warnings

SPF 30 with Retinol by is a Otc medication manufactured, distributed, or labeled by AMCOL Health & Beauty Solutions, Inc., AMCOL Health & Beauty Solutions, Inc DBA AMCOLHousehold and Personal Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 30 WITH RETINOL- homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion 
AMCOL Health & Beauty Solutions, Inc.

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Principal Display Panel – 30 mL Carton Label

healthspan

Nurture your skin

Intensive
Age-Defying
Day Cream
SPF30

nurture

Principal Display Panel – 30 mL Carton Label

Principal Display Panel – 30 mL TubeCarton Label

healthspan

Nurture your skin

Intensive
Age-Defying
Day Cream
SPF30

nurture

Principal Display Panel – 30 mL TubeCarton Label
SPF 30 WITH RETINOL 
homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68634-077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene15 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone40 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
butylene glycol (UNII: 3XUS85K0RA)  
glycerin (UNII: PDC6A3C0OX)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
arachidyl alcohol (UNII: 1QR1QRA9BU)  
dimethicone (UNII: 92RU3N3Y1O)  
glyceryl myristate (UNII: 6992Y81827)  
peg-100 stearate (UNII: YD01N1999R)  
retinol (UNII: G2SH0XKK91)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
erythorbic acid (UNII: 311332OII1)  
glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)  
docosanol (UNII: 9G1OE216XY)  
arachidyl glucoside (UNII: 6JVW35JOOJ)  
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)  
picea abies wood (UNII: 72GZ8K8996)  
bentonite (UNII: A3N5ZCN45C)  
polysorbate 20 (UNII: 7T1F30V5YH)  
sodium hydroxide (UNII: 55X04QC32I)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
edetate disodium anhydrous (UNII: 8NLQ36F6MM)  
chlorphenesin (UNII: I670DAL4SZ)  
phenoxyethanol (UNII: HIE492ZZ3T)  
ethylhexylglycerin (UNII: 147D247K3P)  
titanium dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68634-077-011 in 1 CARTON12/18/202010/13/2023
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/18/202010/13/2023
Labeler - AMCOL Health & Beauty Solutions, Inc. (872684803)
Establishment
NameAddressID/FEIBusiness Operations
AMCOL Health & Beauty Solutions, Inc DBA AMCOLHousehold and Personal Care872684803MANUFACTURE(68634-077) , ANALYSIS(68634-077) , PACK(68634-077)

Revised: 2/2023
 
A

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