Malin and Goetz

Manufacturer
Malin + Goetz | Milbar Laboratories,Inc.
Effective date
2014-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:10

Label at a glance#

ProductMalin and Goetz SPF 30 Face Moisturizer
Active ingredientavobenzone, homosalate, octinoxate, octisalate, oxybenzone
Label structure10 sections

Indications and uses

Helps prevent 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

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure to clean face Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours 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 of 15 or higher and other sun protection measures including: Limit time in ...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
avobenzone 3%sunscreen
homosalate 10%sunscreen
octinoxate 7.5%sunscreen
octisalate 5%sunscreen
oxybenzone 5%sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure to clean face
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor. Smooth onto face and neck until thoroughly absorbed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), c12-15 alkyl ethylhexanoate, dimethicone, glycerin, vp/eicosene copolymer, phenoxyethanol, peg-20 methyl glucose sesquistearate, methyl glucose sesquistearate, cetyl alcohol, potassium cetyl phosphate, acrylates/c10-30 alkyl acrylate cross- polymer, peg-40 stearate, chlorph- enesin, polysorbate 80, cholesterol, ethylhexylglycerin, sodium benzoate, sodium hydroxide, disodium edta, methylisothiazolinone, panthenol, tetrahexyldecyl ascorbate, aloe barbadensis leaf juice powder, allantoin, tocopherol, camellia oleifera leaf extract, epilobium angustifolium flower/leaf/stem extract

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Visit www.malinandgoetz.com or call +1-212-244-7771, M-F, 9am-6pm EST

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
MALIN+GOETZ INC.,
210 WEST 29TH ST.,
NEW YORK, NEW YORK 10001

PRINCIPAL DISPLAY PANEL - 48 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(MALIN+GOETZ)
spf 30 face moisturizer.

BROAD SPECTRUM SPF 30. ALL SKIN TYPES.
APOTHECARY AND LAB—FM-118-48.

BROAD SPECTRUM SPF 30 HELPS PROTECT AGAINST
SUN DAMAGE WHILE GREEN TEA ANTIOXIDANTS PRO-
VIDE PROTECTION AGAINST ENVIRONMENTAL TOXINS
AND FREE RADICALS. GENTLY MOISTURIZES AND BAL-
ANCES ALL SKIN TYPES. NATURAL FRAGRANCE AND
COLOR. DIRECTIONS: APPLY GENEROUSLY AND EVENLY TO
CLEAN FACE 15 MINUTES BEFORE SUN EXPOSURE. USE A
WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6
MONTHS OF AGE: ASK A DOCTOR. SMOOTH ONTO FACE AND
NECK UNTIL THOROUGHLY ABSORBED. WARNINGS: FOR EXT-
ERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN
SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE
WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF:
RASH OR IRRITATION DEVELOPS AND LASTS. KEEP OUT OF
REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY. FORM-
ULATED AND DISTRIBUTED BY: MALIN+GOETZ INC., 210 WEST
29TH ST., NEW YORK, NEW YORK 10001, TEL +1 212 244 7771.
WWW.MALINANDGOETZ.COM. MALIN+GOETZ DOES NOT TEST
ON ANIMALS. MADE IN USA.

1.7fl.oz.℮48ml

PRINCIPAL DISPLAY PANEL - 48 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 48 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-254-502020-01-31C16284748780-19d75b9d0-4768-f424-e053-dadaa90a57ceMalin and Goetz SPF 30 Face Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-254-50Malin and Goetz SPF 30 Face Moisturizer1 in 1 CARTONCREAM11
53634-254-50Malin and Goetz SPF 30 Face Moisturizer48 mL in 1 TUBECREAM481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-254MALIN AND GOETZ SPF 30 FACE MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) CREAM [MALIN + GOETZ]1Legacy NDC, 2 package rows20140906_86dda2da-c05f-4f26-a174-ca893709e003.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOX1
homosalateACTIVE INGREDIENTV06SV4M95S1
octinoxateACTIVE INGREDIENT4Y5P7MUD511
octisalateACTIVE INGREDIENT4X49Y0596W1
oxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
avobenzoneACTIVE MOIETYG63QQF2NOX1
homosalateACTIVE MOIETYV06SV4M95S1
octinoxateACTIVE MOIETY4Y5P7MUD511
octisalateACTIVE MOIETY4X49Y0596W1
oxybenzoneACTIVE MOIETY95OOS7VE0Y1
allantoinINACTIVE INGREDIENT344S277G0Z1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
c12-15 alkyl ethylhexanoateINACTIVE INGREDIENTGQJ580CH831
camellia oleifera leafINACTIVE INGREDIENT5077EL0C601
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
cholesterolINACTIVE INGREDIENT97C5T2UQ7J1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
epilobium angustifolium flowering topINACTIVE INGREDIENT08H094218D1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA1
panthenolINACTIVE INGREDIENTWV9CM0O67Z1
peg-20 methyl glucose sesquistearateINACTIVE INGREDIENT0345752X7U1
peg-40 stearateINACTIVE INGREDIENTECU18C66Q71
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UT1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZ1
tocopherolINACTIVE INGREDIENTR0ZB2556P81
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53634-25453634-254-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 484 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IDROPS / OPHTHALMICNAExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HDROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
cholesterolCHOLESTEROL97C5T2UQ7JINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS52 mgExact identifier — unii candidate
10 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVITREAL0.02 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION / ORAL907 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
42a636d3-b93f-4fad-ae6c-61be99e2afec86dda2da-c05f-4f26-a174-ca893709e0032014-08-13WarningsExact identifier
spl id: 42a636d3-b93f-4fad-ae6c-61be99e2afec
spl set id: 86dda2da-c05f-4f26-a174-ca893709e003

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.