FDA.reportPublic FDA data

Complexion Protection Moisturizer SPF

Manufacturer
USRX LLC
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:22:37

Label at a glance#

ProductComplexion Protection Moisturizer SPF
Active ingredientZINC OXIDE, OCTISALATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ml label50ml label

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate (Ethylhexyl Salicylate) 5%

Zinc Oxide 11.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with ohter sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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 occurs

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.

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear lon-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age:Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Tetradecane, Butyloctyl Salicylate,
C12-15 Alkyl Benzoate, Polyester-8, Cetearyl Olivate, Glycerin, Lauroyl Lysine, Silica,
Polyhydroxystearic Acid, Glyceryl Stearate Citrate, Niacinamide, Pentylene Glycol,
Potassium Cetyl Phosphate, Sorbitan Olivate, Inulin Lauryl Carbamate, 1,2-Hexanediol,
Hydroxyacetophenone, Squalane, Diethylhexyl Syringylidenemalonate, Cetearyl Alcohol,
Acacia Senegal Gum, Lactic Acid, Xanthan Gum, Sodium Stearoyl Glutamate,
Chlorphenesin, Coco-Glucoside, Trisodium Ethylenediamine Disuccinate, Tocopheryl
Acetate (Vitamin E), Tridecane, Sodium Citrate, C13-14 Allkane, Cucumis Sativus
(Cucumber) Fruit Extract, Sodium Hyaluronate, Ascorbic Acid (Vitamin C)

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70809-1912-12026-01-29C16284748780-10191ceaa-683c-198a-e063-dbdaa90aec3eComplexion Protection Moisturizer
70809-1912-22026-01-29C16284748780-10191ceaa-683c-198a-e063-dbdaa90aec3eComplexion Protection Moisturizer
70809-1912-12023-10-20C16284748780-10191ceaa-683c-198a-e063-dbdaa90aec3eComplexion Protection Moisturizer
70809-1912-22023-10-20C16284748780-10191ceaa-683c-198a-e063-dbdaa90aec3eComplexion Protection Moisturizer
70809-1912-12023-07-28C16284748780-10191ceaa-683c-198a-e063-dbdaa90aec3eComplexion Protection Moisturizer
70809-1912-22023-07-28C16284748780-10191ceaa-683c-198a-e063-dbdaa90aec3eComplexion Protection Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1912-1Complexion Protection Moisturizer SPF15 mL in 1 TUBECREAM154
70809-1912-2Complexion Protection Moisturizer SPF1 in 1 BOXCREAM14
70809-1912-2Complexion Protection Moisturizer SPF50 mL in 1 BOTTLECREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1912COMPLEXION PROTECTION MOISTURIZER SPF (ZINC OXIDE, OCTISALATE) CREAM [USRX LLC]4Legacy NDC, 3 package rows20241004_e3103369-39c7-6d4d-e053-2a95a90a5eef.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70809-191270809-1912-1, 70809-1912-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
INULIN LAURYL CARBAMATE48RFF58ESGIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
LAUROYL LYSINE113171Q70BIACT
NIACINAMIDE25X51I8RD4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LACTIC ACID, L-F9S9FFU82NIACT
CUCUMBERYY7C30VXJTIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
CHLORPHENESINI670DAL4SZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ACACIA5C5403N26OIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TRIDECANEA3LZF0L939IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
ZINC OXIDESOI2LOH54ZACTIM
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PENTYLENE GLYCOL50C1307PZGIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLY(LAURYLGLUCOSIDE)-7VB00RDE21RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
XANTHAN GUMTTV12P4NEEIACT
TETRADECANE03LY784Y58IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
WATER059QF0KO0RIACT
CETEARYL OLIVATE58B69Q84JOIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
SORBITAN OLIVATEMDL271E3GRIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OCTISALATE4X49Y0596WACTIB

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
236fcb8e-5b99-86b3-e063-6394a90a39c7e3103369-39c7-6d4d-e053-2a95a90a5eef2024-10-01WarningsExact identifier
spl id: 236fcb8e-5b99-86b3-e063-6394a90a39c7
spl set id: e3103369-39c7-6d4d-e053-2a95a90a5eef

Reported adverse events (FAERS/openFDA)#

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