FDA.reportPublic FDA data

Sun Shield SPF 50

Manufacturer
ALLURE LABS INC
Effective date
2017-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:33

Label at a glance#

ProductSun Shield SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide - 8.6%

Titanium Dioxide - 6.5%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 15 minutes prior to sun exposure.
  • Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in sun sun, especially from 10 am - 2 pm.
  • wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Water (Aqua), Cyclopenatasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Alminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Vitis Vinifera, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Tocopherol, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Isomalt, Dimethicone / Vinyl Dimethicone Crosspolymer Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Ascorbic Acid, Ascorbyl Palmitate, Citric Acid, Sodium Benzoate.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Call toll free 1-800 830-1491 in the USA.

info@atzen.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Toll free in USA: 800.830.1491

Email: info@atzen.com

www.atzen.com

Developed in France. Made in USA.

Sun Shield SPF 50Sun Shield SPF 50

Sun Shield SPF 50Sun Shield SPF 50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62742-4161-22023-01-30C16284748780-1f386c64a-02d0-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4161-1Sun Shield SPF 5090 mL in 1 TUBECREAM901
62742-4161-2Sun Shield SPF 501 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4161SUN SHIELD SPF 50 (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [ALLURE LABS INC]1Legacy NDC, 2 package rows20171220_63397308-85b1-45e1-b274-0cea6f7154ff.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-416162742-4161-1, 62742-4161-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
VITIS VINIFERA FRUIT RIND653OHN32Q1IACT
HEXYL LAURATE4CG9F9W01QIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)H5BJH23Z9AIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ETHYLHEXYL PALMITATE2865993309IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TRIEPOXYCYCLOHEXASILANE066Q83563RIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
66f2df85-d6f2-4928-8e96-f2bc14f2988e63397308-85b1-45e1-b274-0cea6f7154ff2017-12-15WarningsExact identifier
spl id: 66f2df85-d6f2-4928-8e96-f2bc14f2988e
spl set id: 63397308-85b1-45e1-b274-0cea6f7154ff

Reported adverse events (FAERS/openFDA)#

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