FDA.reportPublic FDA data

SPF 30 face Moisturizer

Manufacturer
Malin and Goetz Inc | Milbar Laboratories,Inc.
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:27

Label at a glance#

ProductSPF 30 face Moisturizer
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient        Purpose

Avobenzone 3%        sunscreen

Homosalate 10%      sunscreen

Octinoxate 7.5%       sunscreen

Octisalate 2.75%      sunscreen

Oxybenzone 5%       sunscreen

OTC - PURPOSE SECTION

Uses

  • Helps prevent sunburn
  • If used as directed with other sun proctection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • Retains SPF up to 80 minutes of activity in the water

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally and evenly to dry skin 15 minutes before sun exposure and as often as needed.
  • Re-apply at least every 2 hours; after 80 minutes of  swimming or perspiring; immediately after towel drying.
  • Children under 6 months of age, consult your physician
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regualarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  •   Limit time in the sun from 10am-2pm
  • wear long sleeve shirts, pants, hats and sunglasses

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(Malin + Goetz)

SPF 30 Face Moisturizer

Broad Spectrum SPF 30 All skin types

Water Resistant

1.7 fl. oz. 50 ml

cartoncarton

tubetube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-255-022023-01-30C16284748780-1f386c649-bad8-0266-e053-dadaa90a7c1aSPF 30 Face Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-255-01SPF 30 face Moisturizer50 mL in 1 JARLOTION503
53634-255-02SPF 30 face Moisturizer1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-255SPF 30 FACE MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [MALIN AND GOETZ INC]3Legacy NDC, 2 package rows20210128_90449ec4-37e7-4b1b-a98f-6a3845cce0e9.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53634-25553634-255-01, 53634-255-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE92RU3N3Y1OIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
ALOE FEROX LEAF0D145J8EMEIACT
SHEANUT OILO88E196QRFIACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
SODIUM HYDROXIDE55X04QC32IIACT
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PEG-40 STEARATEECU18C66Q7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

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
b9d30fe3-671f-59a0-e053-2a95a90a3bd690449ec4-37e7-4b1b-a98f-6a3845cce0e92021-01-26WarningsExact identifier
spl id: b9d30fe3-671f-59a0-e053-2a95a90a3bd6
spl set id: 90449ec4-37e7-4b1b-a98f-6a3845cce0e9

Reported adverse events (FAERS/openFDA)#

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