FDA.reportPublic FDA data

RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30

Manufacturer
RADICAL BEAUTY USA INC | Alban Muller International
Effective date
2015-03-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:42:05

Label at a glance#

ProductRADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 40 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 this risk, regularly use a sunscreen wish a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, ...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 7.75%
Titanium Dioxide 5.87%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

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 if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:
  • after 40 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 this risk, regularly use a sunscreen wish a broad spectrum SPF 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
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylyl Methicone, PEG-10 Dimethicone, Isododecane, Titanium Dioxide, Alcohol, Caprylic/Capric Triglyceride, Polymethylsilsesquioxane, Methyl Methacrylate Crosspolymer, Sea Salt, Alumina, Methicone, Polyhydroxystearic Acid, Phenoxyethanol, Mica, Disodium EDTA, PEG-10, Glycerin, Isostearic Acid, Iron Oxides, Adenosine, Lecithin, Ascorbyl Tetraisopalmitate, Niacinamide, Tocopherol, Diamond Powder, Allantoin, Xanthum Gum, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Pentylene Glycol, Superoxide Dismutase, Tromethamine

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-519-1852

Principal Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RADICAL skincare

SKIN PERFECTING
SCREEN
SPF 30

Non-Chemical Sunscreen
UV Broad Spectrum
High Protection

TRYLACEL ​™

40mL 1.35 FL. OZ.

For all skin types.

The perfect partner of any Radical regimen, this lightweight matte lotion offers non-chemical sunscreen with high sunburn protection, and light diffusing pigments to visibly reduce the appearance of wrinkles and imperctions, a hint of tint for the perfect healthy radiance.

Shake well before use.
Use over moisturizer, prior to sun exposure. Keep out of eyes. Stop use if irritation occurs or increases. If irritation persists, consult a health care practitioner.

RADICAL BEAUTY
20 rue Cambon
75001 PARIS - FRANCE
made in France
www.radicalskincare.com

labellabel

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62510-001-402020-01-31C16284748780-19d75b9d0-2df1-f424-e053-dadaa90a57ceRADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62510-001-40RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 301 in 1 CARTONLOTION13
62510-001-40RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 3040 mL in 1 BOTTLELOTION403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62510-001RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [RADICAL BEAUTY USA INC]3Legacy NDC, 2 package rows20150331_aea07c57-9c15-4662-9eca-ff049d8ecb35.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3
ZINC CATIONACTIVE MOIETY13S1S8SF373
ADENOSINEINACTIVE INGREDIENTK72T3FS5673
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
ALLANTOININACTIVE INGREDIENT344S277G0Z3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
ASCORBYL TETRAISOPALMITATEINACTIVE INGREDIENT47143LT58A3
CAPRYLYL TRISILOXANEINACTIVE INGREDIENTQ95M2P1KJL3
DIAMONDINACTIVE INGREDIENT6GRV67N0U23
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B03
ISODODECANEINACTIVE INGREDIENTA8289P68Y23
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00623
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
MICAINACTIVE INGREDIENTV8A1AW08803
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD43
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYETHYLENE GLYCOL 500INACTIVE INGREDIENT761NX2Q08Y3
SEA SALTINACTIVE INGREDIENT87GE52P74G3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P83
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2V3
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62510-00162510-001-40

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
WATER059QF0KO0RIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SEA SALT87GE52P74GIACT
ALUMINUM OXIDELMI26O6933IACT
PHENOXYETHANOLHIE492ZZ3TIACT
MICAV8A1AW0880IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL 500761NX2Q08YIACT
GLYCERINPDC6A3C0OXIACT
ISOSTEARIC ACIDX33R8U0062IACT
FERRIC OXIDE RED1K09F3G675IACT
ADENOSINEK72T3FS567IACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
NIACINAMIDE25X51I8RD4IACT
TOCOPHEROLR0ZB2556P8IACT
DIAMOND6GRV67N0U2IACT
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PENTYLENE GLYCOL50C1307PZGIACT
TROMETHAMINE023C2WHX2VIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 328 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062GEL / TOPICAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VGEL / TOPICAL56 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.24 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / ORAL1.21 mg/1mlExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates

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
1294cf87-f0c3-4969-e054-00144ff88e88aea07c57-9c15-4662-9eca-ff049d8ecb352015-03-31WarningsExact identifier
spl id: 1294cf87-f0c3-4969-e054-00144ff88e88
spl set id: aea07c57-9c15-4662-9eca-ff049d8ecb35

Reported adverse events (FAERS/openFDA)#

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