FDA.reportPublic FDA data

Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50

Manufacturer
ENGLEWOOD LAB, INC.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:00

Label at a glance#

ProductAnua Zero-Cast Moisturizing Finish Sunscreen SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

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

Dosage and administration

For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months: Ask a doctor 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%
Homosalate 7.0%
Octisalate 5.0%
Octocrylene 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use:
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Children under 6 months: Ask a doctor
  • 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 long-sleeved shirts, pants, hats and sunglasses

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolym er, Cetearyl Alcohol, Niacinamide, So dium Stearoyl Glutamate, Ammonium Polyacryloyldimethyl Taurate, Hydrox yacetophenone, Phenoxyethanol, To copheryl Acetate, Panthenol, Pentaer ythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, 1,2-Hexan ediol, Sodium Hyaluronate

Questions?

OTC - QUESTIONS SECTION

+1-888-899-9083 Monday–Friday (9 a.m.–5 p.m. EST) www.anua.us

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14268-169-50Anua Zero-Cast Moisturizing Finish Sunscreen SPF 5050 mL in 1 TUBELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14268-169ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ENGLEWOOD LAB, INC.]1Current NDC, 1 package rows20250412_edf07b7f-46fb-4915-b2ea-83d852617f60.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14268-16914268-169-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
NIACINAMIDE25X51I8RD4IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATEF01RIY4371IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
XANTHAN GUMTTV12P4NEEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM HYALURONATEYSE9PPT4THIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
ndc (package): 14268-169-50
ndc (product): 14268-169
ndc11 (package): 14268016950
spl id: 3271c59b-2953-b798-e063-6294a90a0a31
spl set id: edf07b7f-46fb-4915-b2ea-83d852617f60

Reported adverse events (FAERS/openFDA)#

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