FDA.reportPublic FDA data

Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen

Manufacturer
Colorescience
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:44

Label at a glance#

ProductSunforgettable Tint du Soleil Foundation SPF 30 Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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. Works best on moisturized skin. Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: ask a doctor. 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 su...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 4.8%Sunscreen
Zinc Oxide 6.7%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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
  • Reapply:
    • After 40 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours. Children under 6 months: ask a doctor.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Water, Mica, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol, Caprylyl Glycol, Dimethiconol, Silica, Jojoba Esters, Lauroyl Lysine, Polyhydroxystearic Acid, Ahnfeltia Concinna Extract, Glyceryl Behenate/Eicosadioate, Alumina, Sodium Lauroyl Lactylate, Phenethyl Alcohol, Tocopheryl Acetate, Cananga Odorata Flower Oil, Carbomer, Sodium Lactate, Sodium Ascorbyl Phosphate, Fusanus Spicatus Wood Oil, Polysorbate 20, Ceramide NP, Ceramide AP, Ceramide EOP, Triethoxycaprylylsilane, Phytosphingosine, Cholesterol, Xanthan Gum, Ethylhexylglycerin, Pelargonium Graveolens Flower Oil, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Chlorphenesin, Sodium Dehydroacetate, Sodium Benzoate, Sorbic Acid, Linalool, Farnesol, Iron Oxides (CI 77491, CI 77492, CI 77499).

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 866.426.5673

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

TINT DU
SOLEIL®

WHIPPED FOUNDATION

  • Creamy and lightweight
  • Comforting hydration
  • Helps improve
    appearance of lines
    and wrinkles

30
Broad Spectrum
SPF 30 Sunscreen

ALL-MINERAL ACTIVES
WATER/SWEAT RESISTANT
(40 MINUTES)

Net Wt. 1 fl. oz. / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68078-004-022021-10-06C16284748780-1ba0f9c33-4c55-a910-e053-dadaa90a0b85Sunforgettable ® Tint du Soleil™ Foundation SPF 30 Sunscreen
68078-004-052021-10-06C16284748780-1ba0f9c33-4c55-a910-e053-dadaa90a0b85Sunforgettable ® Tint du Soleil™ Foundation SPF 30 Sunscreen
68078-004-022021-01-29C16284748780-1ba0f9c33-4c55-a910-e053-dadaa90a0b85Sunforgettable ® Tint du Soleil™ Foundation SPF 30 Sunscreen
68078-004-052021-01-29C16284748780-1ba0f9c33-4c55-a910-e053-dadaa90a0b85Sunforgettable ® Tint du Soleil™ Foundation SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-004-02Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen1 mL in 1 PACKETLIQUID15
68078-004-05Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen30 mL in 1 TUBELIQUID305
68078-004-05Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-004SUNFORGETTABLE TINT DU SOLEIL FOUNDATION SPF 30 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]5Current NDC, Legacy NDC, 3 package rows20241215_219e2ef4-e977-4527-8999-14b27d5a7a33.zip

Products#

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

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-00468078-004-05, 68078-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
MICAV8A1AW0880IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LAUROYL LYSINE113171Q70BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
AHNFELTIOPSIS CONCINNASMF2K46G8DIACT
SANTALUM SPICATUM OILH9LVS6REV4IACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
ALUMINUM OXIDELMI26O6933IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
YLANG-YLANG OIL8YOY78GNNXIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENESINI670DAL4SZIACT
CERAMIDE NP4370DF050BIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
SODIUM BENZOATEOJ245FE5EUIACT
Sodium Lauroyl Lactylate7243K85WFOIACT
Ceramide APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
PhytosphingosineGIN46U9Q2QIACT
Pelargonium Graveolens Flower Oil3K0J1S7QGCIACT
Cholesterol97C5T2UQ7JIACT
Ethylhexylglycerin147D247K3PIACT
LINALOOL, (+/-)-D81QY6I88EIACT
FarnesolEB41QIU6JLIACT

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
Sunforgettable Tint du Soleil Foundation SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescience219e2ef4-e977-4527-8999-14b27d5a7a332024-12-12WarningsExact identifier
ndc (package): 68078-004-05
ndc (package): 68078-004-02
ndc (product): 68078-004
ndc11 (package): 68078000402
ndc11 (package): 68078000405
spl id: 5a4fd09b-5260-4012-a9d1-8ee29c06e662
spl set id: 219e2ef4-e977-4527-8999-14b27d5a7a33

Reported adverse events (FAERS/openFDA)#

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