FDA.reportPublic FDA data

Spa Pharma Olive Oil Moisturizing Cream

Manufacturer
Peer Pharma Ltd.
Effective date
2016-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:30

Label at a glance#

ProductSpa Pharma Olive Oil Moisturizing Cream
Active ingredientOCTOCRYLENE, OCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 5%

Octisalate 5%

Octinoxate 7.5%

Avobenzone 3%

Homosalate 2%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Provides SPF 25 protection

Skin moisturizer

INDICATIONS & USAGE SECTION

To Use: Smooth onto face.

For Sunscreen Use: Apply liberally 15 minutes before sun exposure. 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.

DOSAGE & ADMINISTRATION SECTION

Smooth on to face

INACTIVE INGREDIENT SECTION

Water, Cetearyl Alcohol & Cetearyl Glucoside, Cyclopentasiloxane, Isohexadecane, Stearate & Peg-100 stearate, Glycerin, Simmondsia Chimensis (Jojoba) seed oil, Butyrospermum Parkii (shea) Butter, Potassim Cetyl Phosphate, Niacinamide (Vit.B3), Dehydroacetic Acid & Benzoic Acid & Phenoxyethanol, Dimethicone, Maris Sal (from dead sea), * Fragrance (supplement) , Allantoin, Aloe Barbadensis (Aloe Vera) Leaf extract, Retinyl Palmitate, Persea Grattissima, Olea Europaea (Olive) fruit oil, Tocopheryl Acetate (vit.E), Panthenol (vit. B5), Anthemis Nobilis (Chamomile) extract, Punica Granatum (Pomegranate) extract, Camelia Sinensis extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spa Pharma Olive Oil Moisturizing Cream SPF25Spa Pharma Olive Oil Moisturizing Cream SPF25

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1604-12020-01-31C16284748780-19d75b9d0-06f1-f424-e053-dadaa90a57ceSpa Pharma Olive Oil Moisturizing Cream SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1604-1Spa Pharma Olive Oil Moisturizing Cream50 mL in 1 CONTAINERCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1604SPA PHARMA OLIVE OIL MOISTURIZING CREAM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE CREAM) CREAM [PEER PHARMA LTD.]2Legacy NDC, 1 package rows20160323_aae4c026-35b0-464b-ac42-a63192e0ad2d.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-160469435-1604-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISOHEXADECANE918X1OUF1EIACT
GLYCERINPDC6A3C0OXIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
SHEA BUTTERK49155WL9YIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
SEA SALT87GE52P74GIACT
ALOE VERA LEAFZY81Z83H0XIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
CAMELINA SATIVA WHOLEW42JFE4HONIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB

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
2eba7803-fbc8-17fe-e054-00144ff88e88aae4c026-35b0-464b-ac42-a63192e0ad2d2016-03-23Exact identifier
spl id: 2eba7803-fbc8-17fe-e054-00144ff88e88
spl set id: aae4c026-35b0-464b-ac42-a63192e0ad2d

Reported adverse events (FAERS/openFDA)#

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