FDA.reportPublic FDA data

XXL Demi Make Up SPF 50

Manufacturer
Peer Pharma Ltd.
Effective date
2018-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:39

Label at a glance#

ProductXXL Demi Make Up SPF 50
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

demi make updemi make up

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7%

Octocrylene 5%

Octisalate 5%

Avobenzone 3%

Homosalate 2%

Titanium Dioxide 3%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Provides SPF 50 protection

INDICATIONS & USAGE SECTION

Directions for use: gently apply "gold" demi makeup to face and neck prior to sun exposure for instant coverage and correction as well as for protection. Reapply as needed. ​

WARNINGS SECTION

DOSAGE & ADMINISTRATION SECTION

Directions for use: gently apply "gold" demi makeup to face and neck prior to sun exposure for instant coverage and correction as well as for protection. Reapply as needed.

INACTIVE INGREDIENT SECTION

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1803-12021-01-29C16284748780-1ba0f9c33-37b0-a910-e053-dadaa90a0b85Gold Cosmetics XXL Demi Make Up SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1803-1XXL Demi Make Up SPF 50100 mL in 1 CONTAINERCREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1803XXL DEMI MAKE UP SPF 50 (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, CREAM) CREAM [PEER PHARMA LTD.]1Legacy NDC, 1 package rows20180524_6cf544a1-52ae-962a-e053-2a91aa0ab67f.zip

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
69435-180369435-1803-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
NYLON-12446U8J075BIACT
ALLANTOIN344S277G0ZIACT
DOCOSANOL9G1OE216XYIACT
DEHYDROACETIC ACID2KAG279R6RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERYL OLEATE4PC054V79PIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
FERRIC OXIDE RED1K09F3G675IACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYGLYCERIN-10P9060O936AIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
WATER059QF0KO0RIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
6cf544a1-52b0-962a-e053-2a91aa0ab67f6cf544a1-52ae-962a-e053-2a91aa0ab67f2018-05-24Exact identifier
spl id: 6cf544a1-52b0-962a-e053-2a91aa0ab67f
spl set id: 6cf544a1-52ae-962a-e053-2a91aa0ab67f

Reported adverse events (FAERS/openFDA)#

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