FDA.reportPublic FDA data

PREDIRE PARIS skin shield protector mineral defense cream

Manufacturer
Guangzhou Fantesy Biotechnology Co.,Ltd
Effective date
2025-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:07

Label at a glance#

ProductPREDIRE PARIS skin shield protector mineral defense cream
Active ingredientETHYLHEXYL SALICYLATE, HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE
Label structure12 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

Apply liberally 15 minutes before sun exposure. Reapply every two hours. Water- resistant up to 40 minutes.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10%

Ethylhexyl Salicylate 8%

Homosalate 5%

Ethylhexyl Methoxycinnamate 3%

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

Do not use on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children . If product is swallowed . get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply every two hours. Water-
resistant up to 40 minutes.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Collagen, Caprylic/Capric Triglyceride,
Vitamin C, PEG/PPG- 17 / 6 Copolymer, Hyaluronic Acid,
Betaine, Ammonium Acryloyldimethyltaurate/vp Copolymer,
Tocopherol, Polyacrylamide, lron oxides, C13- 14 Isoparaffin,
Laureth-7, Sodium Acrylate/Sodium Acryloyldimethyl Taurate
Copolymer, Fragrance, Phenoxyethanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-012-01PREDIRE PARIS skin shield protector mineral defense cream50 mL in 1 BOTTLECREAM501

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83447-01283447-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG/PPG-17/6 COPOLYMERP5QZM4T259IACT
HYALURONIC ACIDS270N0TRQYIACT
FERROUS OXIDEG7036X8B5HIACT
BETAINE3SCV180C9WIACT
TOCOPHEROLR0ZB2556P8IACT
LAURETH-7Z95S6G8201IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYL SALICYLATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
ETHYLHEXYL METHOXYCINNAMATE4Y5P7MUD51ACTIB
AQUA059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COLLAGEN, SOLUBLE, FISH SKIN8JC99XGU4WIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
OCTOCRYLENE5A68WGF6WMACTIB
PEACH3OKE88I3QGIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT

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
PREDIRE PARIS skin shield protector mineral defense creamPREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAMGuangzhou Fantesy Biotechnology Co.,Ltd3a7c1345-532f-b38f-e063-6394a90a52452025-07-21WarningsExact identifier
ndc (package): 83447-012-01
ndc (product): 83447-012
ndc11 (package): 83447001201
spl id: 3a7c161f-0fad-27f5-e063-6294a90a6c62
spl set id: 3a7c1345-532f-b38f-e063-6394a90a5245

Reported adverse events (FAERS/openFDA)#

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