FDA.reportPublic FDA data

Complexion Protection Moisturizer SPF

Manufacturer
USRX LLC
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:22:31

Label at a glance#

ProductComplexion Protection Moisturizer SPF
Active ingredientOCTISALATE, OCTINOXATE, AVOBENZONE, BENZOPHENONE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

.05 oz.05 oz

1.7 oz1.7 oz

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT -

Benzophenone 3.6%

Avobenzone 1%

Octinoxate 7.5%

Octisalate 5%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE - On damaged or broken skin

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF A RASH OCCURRS

DOSAGE & ADMINISTRATION SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

INACTIVE INGREDIENT SECTION

Aqua (Water), Caprylic/Capric Triglyceride, Corn Starch Modified, Cetearyl Olivate, Diethylhexyl 2,6-Naphthalate, C12-15 Alkyl Benzoate, Sorbitan Olivate, Gluconolactone, Squalane, Glycerin, Cyclopentasiloxane, Tocopheryl Acetate (D-alpha), Sodium Hyaluronate (L), Xanthan Gum, Carbomer, Aminomethyl Propanol, Sodium Benzoate, Phenethyl Alcohol, Caprylyl Glycol, Phenoxyethanol, Trisodium Ethylenediamine Disuccinate, Potassium Sorbate​

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70809-1902-12026-01-29C16284748780-149896155-c2f6-586f-e063-e6dba90add90Complexion Protection Moisturizer SPF 30
70809-1902-22026-01-29C16284748780-149896155-c2f6-586f-e063-e6dba90add90Complexion Protection Moisturizer SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1902-1Complexion Protection Moisturizer SPF50 mL in 1 TUBECREAM507
70809-1902-2Complexion Protection Moisturizer SPF12 mL in 1 TUBECREAM127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1902COMPLEXION PROTECTION MOISTURIZER SPF (BENZOPHENONE, AVOBENZONE, OCTINOXATE, OCTISALATE CREAM) CREAM [USRX LLC]7Legacy NDC, 2 package rows20241004_8d343fec-85a7-613b-e053-2a95a90a4a78.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70809-190270809-1902-1, 70809-1902-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM BENZOATEOJ245FE5EUIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
STARCH, CORNO8232NY3SJIACT
WATER059QF0KO0RIACT
CETEARYL OLIVATE58B69Q84JOIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
GLUCONOLACTONEWQ29KQ9POTIACT
SORBITAN OLIVATEMDL271E3GRIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTISALATE4X49Y0596WACTIB
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
BENZOPHENONE701M4TTV9OACTIB

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
236fc9b0-64d8-88cd-e063-6394a90a06a88d343fec-85a7-613b-e053-2a95a90a4a782024-10-01WarningsExact identifier
spl id: 236fc9b0-64d8-88cd-e063-6394a90a06a8
spl set id: 8d343fec-85a7-613b-e053-2a95a90a4a78

Reported adverse events (FAERS/openFDA)#

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