Soleil Superieur Body SPF 50 US

Manufacturer
RV Skincare LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:14

Label at a glance#

ProductSoleil Superieur Body SPF 50 US
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

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

Dosage and administration

• For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • 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, espec...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 2.60%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

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

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 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 • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • 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 • Children under 6 months of age: Ask a doctor






Sun Protection Measures.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Water, Eau), Ethylhexyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Caprylyl Glycol, Polyacrylate-15, PEG-10 Dimethicone,  Carnosine, Lecithin, Polyacrylate-17, Silybin, Tocopherol, Glycerin, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hexylene Glycol, C11-15 Pareth-7, C11-15 Pareth-40, Parfum (Fragrance), Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Disodium EDTA, Potassium Sorbate,  Potassium Hydroxide, Citric Acid. 

Questions or comments?

OTC - QUESTIONS SECTION

Call , M – F 8am – 5pm CST. 1-866-986-7083

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package06Outer Package06Inner Package06Inner Package06Box4Box4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82691-145-00Soleil Superieur Body SPF 50 US1 in 1 CARTONCREAM13
82691-145-00Soleil Superieur Body SPF 50 US120 mL in 1 BOTTLE, PUMPCREAM1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82691-145SOLEIL SUPERIEUR BODY SPF 50 US (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [RV SKINCARE LLC]3Legacy NDC, 2 package rows20231108_1e94e04e-e264-44d2-991c-d6229cf034b0.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82691-14582691-145-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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
09898669-2893-e17b-e063-6294a90a45c71e94e04e-e264-44d2-991c-d6229cf034b02023-11-06WarningsExact identifier
spl id: 09898669-2893-e17b-e063-6294a90a45c7
spl set id: 1e94e04e-e264-44d2-991c-d6229cf034b0

Reported adverse events (FAERS/openFDA)#

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