FDA.reportPublic FDA data

Soleil Broad Spectrum SPF-15

Product NDC
69630-001
11-digit product format
696300001
Labeler code
69630
Product ID
69630-001_5973fb6f-10df-4b7b-9d62-fc7ea4ffb845
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
The Soleil Group, LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-13
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
5 mg/mL; mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69630-001-152020-01-31C16284748780-19d75b9d0-1c7e-f424-e053-dadaa90a57ceSoleil SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69630-001-15Soleil Broad Spectrum SPF-15177.4 mL in 1 BOTTLE, SPRAYSPRAY177.41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
OCTISALATEACTIVE MOIETY4X49Y0596WSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ARTEMISIA PALLENS WHOLEINACTIVE INGREDIENT39JKR5IL2GSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEINACTIVE INGREDIENTU73D397055SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CARROTINACTIVE INGREDIENTL56Z1JK48BSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JOSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CITRUS AURANTIUM FLOWER OILINACTIVE INGREDIENTD4BGE91OXHSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CITRUS AURANTIUM FRUITINACTIVE INGREDIENTDQD16J2B5OSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CITRUS LIMON FRUIT OILINACTIVE INGREDIENT0HNC1J1YEDSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CITRUS NOBILISINACTIVE INGREDIENT8MFF77J91VSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
CITRUS SINENSIS FRUIT OILINACTIVE INGREDIENTWV48LBL15QSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ETHYL ACETOACETATEINACTIVE INGREDIENTIZP61H3TB1SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
EUCALYPTUS GLOBULUS WHOLEINACTIVE INGREDIENTSI1P2XF3M3SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
FUCUS VESICULOSUSINACTIVE INGREDIENT535G2ABX9MSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ISOAMYL ACETATEINACTIVE INGREDIENTZ135787824SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
ISOBUTYL ACETATEINACTIVE INGREDIENT7CR47FO6LFSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
JASMINUM SAMBAC WHOLEINACTIVE INGREDIENT1Z81V275I0SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMERINACTIVE INGREDIENT39DK5WQ2PRSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
OPOPANAX CHIRONIUM WHOLEINACTIVE INGREDIENT0LGQ3H5EXRSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
PEG/PPG-17/6 COPOLYMERINACTIVE INGREDIENTP5QZM4T259SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
PIPERONALINACTIVE INGREDIENTKE109YAK00SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
SALVIA SCLAREA SEED OILINACTIVE INGREDIENTJK0RP5O3HWSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YISOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1
waterINACTIVE INGREDIENT059QF0KO0RSOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69630-001SOLEIL BROAD SPECTRUM SPF-15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]1Legacy NDC, 1 package rows20150227_33e4bbda-0f86-4b42-b7bd-5317ef86d36c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69630-001-1569630000115177.4 mL in 1 BOTTLE, SPRAY177.4 mlHistorical