SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion 
Malin and Goetz 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.

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SPF 30 Face Moisturizer

Active Ingredient        Purpose

Avobenzone 3%        sunscreen

Homosalate 10%      sunscreen

Octinoxate 7.5%       sunscreen

Octisalate 2.75%      sunscreen

Oxybenzone 5%       sunscreen

Uses

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

Stop use and ask a doctor if:  Rash or irritation develops and lasts.

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

Water(Aqua), Butyloctyl Salicylate, Dimethicone, Corn Start Modified, Hexylene Glycol, VP/Eicosene Copolymer, Glcyerin, Cetearyl Alcohol, PEG-12 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Panthenol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butyrospermum Parkii (shea) Oil, Epilobium Angustifolium Flower/leaf/stem extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Stearate, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Calcium Pantothenate, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Potassium Sorbate, PEG-40 Stearate, Phenoxyethanol

(Malin + Goetz)

SPF 30 Face Moisturizer

Broad Spectrum SPF 30 All skin types

Water Resistant

1.7 fl. oz. 50 ml

carton

tube

SPF 30 FACE MOISTURIZER 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.75   in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5   in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE FEROX LEAF (UNII: 0D145J8EME)  
SHEANUT OIL (UNII: O88E196QRF)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53634-255-021 in 1 CARTON12/05/2017
1NDC:53634-255-0150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/05/2017
Labeler - Malin and Goetz Inc (138615930)
Establishment
NameAddressID/FEIBusiness Operations
Milbar Laboratories,Inc.195556790manufacture(53634-255)

Revised: 1/2021
Document Id: b9d30fe3-671f-59a0-e053-2a95a90a3bd6
Set id: 90449ec4-37e7-4b1b-a98f-6a3845cce0e9
Version: 3
Effective Time: 20210126
 
Malin and Goetz Inc