Soleil Broad Spectrum SPF 30 Sunscreen Body Creme

Manufacturer
Soleil Group, LLC | Pure Source, LLC
Effective date
2017-02-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 01:20:11

Label at a glance#

ProductSoleil Broad Spectrum SPF 30 Sunscreen Body Creme
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
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.

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply • immediately after swimming, sweating or towel drying • at least every 2 hours • Children under 6 months: Ask a doctor • 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 with a Broad Spectrum ...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Titanium Dioxide 3.5%

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.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

A-bisabolol, algae extract, aloe barbadensis leaf (aloe vera gel) juice*, aqua (deionized water), camellia sinensis leaf (green tea) extract*, carthamus tinctorius (safflower) oil*, cetearyl alcohol, citrullus lanatus (watermelon) extract, citrus aurantifolia fruit oil, citrus aurantium dulcis peel oil, citrus limon peel oil, citrus reticulata leaf oil, commiphora myrrha resin oil, cyclomethicone, dimethicone, gluconolactone, glycerin*, helianthus annuus (sunflower) oil*, isopropyl palmitate, menthapiperita stem/leaf oil, mentha viridis leaf oil, microcrystalline wax, myristica fragrans kernel oil, pogostemon cablin oil, rosa damascena flower oil, salvia scalrea oil, santalum spicata wood oil, sdoium benzoate, tetrahexyldecyl ascorbate (vitamin C), thymus vulgaris oil, tocopherol acetate (vitamin E). *Organic 68.77%

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

OTC - STOP USE SECTION

if 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
• Use a water resistant sunscreen if swimming or sweating
• Reapply
• immediately after swimming, sweating or towel drying
• at least every 2 hours
• Children under 6 months: Ask a doctor
• 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 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

Other Information:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sunlight

Questions or comments:

OTC - QUESTIONS SECTION

Call 917-338-7291

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxLabelBoxLabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD514
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP4
OCTINOXATEACTIVE MOIETY4Y5P7MUD514
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S4
CITRUS AURANTIIFOLIA FRUIT OILINACTIVE INGREDIENT7937R189CB4
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O4
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B04
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M4
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY4
MYRRH OILINACTIVE INGREDIENTH74221J5J44
ORANGE PEELINACTIVE INGREDIENTTI9T76XD444
PATCHOULI OILINACTIVE INGREDIENTF3IN55X5PO4
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH4
ROSA DAMASCENA FLOWER OILINACTIVE INGREDIENT18920M3T134
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS4
SALVIA SCLAREA SEED OILINACTIVE INGREDIENTJK0RP5O3HW4
SANTALUM SPICATUM OILINACTIVE INGREDIENTH9LVS6REV44
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SPEARMINT OILINACTIVE INGREDIENTC3M81465G54
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI4
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ4
THYME OILINACTIVE INGREDIENT2UK410MY6B4
WATERINACTIVE INGREDIENT059QF0KO0R4
WATERMELONINACTIVE INGREDIENT231473QB6R4

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69630-63969630-639-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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 4 · 219 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM, AUGMENTED / TOPICAL7.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5CAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5OINTMENT / TOPICALNAExact identifier — unii candidate
7 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5SUSPENSION / ORAL0.59 mg/20mlExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM, EXTENDED RELEASE / TRANSDERMAL187.5 mgExact identifier — unii candidate
8 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii candidate
28 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5PASTE, DENTIFRICE / DENTAL27.6 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 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
07a7ae56-fa99-3c12-e063-6394a90a3f977f7e4be3-2b5b-4bc1-a3f9-b16a708dc6a22023-10-14WarningsExact identifier
spl set id: 7f7e4be3-2b5b-4bc1-a3f9-b16a708dc6a2

Reported adverse events (FAERS/openFDA)#

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