FDA.reportPublic FDA data

RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY

Manufacturer
SANTO REMEDIO LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:01

Label at a glance#

ProductRADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of swimming or sweating. If used as as directed with other sun protection measures (see directions), decreases the risk of cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months of age: ask a doctor. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad  Spectrum SPF value of 15 or higher and other sun protection mea...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6% Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • If used as as directed with other sun protection measures (see directions), decreases the risk of 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 doctor if

OTC - STOP USE SECTION

  • 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.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months of age: ask a doctor.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad  Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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

Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Raspberry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate Triethoxycaprylylsilane

Questions?

OTC - QUESTIONS SECTION

(855) REMEDIO

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

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
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81352-521-00RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY50 mL in 1 BOTTLESOLUTION502
81352-521-00RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY1 in 1 BOXSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81352-521RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF-42 HONEY (TITANIUM DIOXIDE, ZINC OXIDE) SOLUTION [SANTO REMEDIO LLC]2Current NDC, 2 package rows20231106_867a88df-9a18-447f-8301-2ec91566302e.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81352-52181352-521-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
COCONUT OILQ9L0O73W7LIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
DIMETHICONE92RU3N3Y1OIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
FERRIC OXIDE RED1K09F3G675IACT
RASPBERRY4N14V5R27WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
ndc (package): 81352-521-00
ndc (product): 81352-521
ndc11 (package): 81352052100
spl id: 0976c8f2-de9c-fb24-e063-6394a90a04dd
spl set id: 867a88df-9a18-447f-8301-2ec91566302e

Reported adverse events (FAERS/openFDA)#

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