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 TubeCarton Label

healthspan

Nurture your skin

Intensive
Age-Defying
Day Cream
SPF30

nurture

SPF 30 WITH RETINOL 
homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	15 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	40 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-077-01	1 in 1 CARTON	12/18/2020	10/13/2023
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		12/18/2020	10/13/2023

Labeler - AMCOL Health & Beauty Solutions, Inc. (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc DBA AMCOLHousehold and Personal Care		872684803	MANUFACTURE(68634-077) , ANALYSIS(68634-077) , PACK(68634-077)

Revised: 2/2023

Document Id: 5cd6eacf-684d-4b61-afad-627c6066f4f2

34390-5

Set id: e3fa9ff8-d60f-4d2a-be8c-9221c42a7b02

Version: 1

Effective Time: 20230210

 

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