FDA.reportPublic FDA data

Double Use Compact SPF 15 gold deluxe edition Medium 7

Manufacturer
Bel Star S.A. (Colombia)
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:03:38

Label at a glance#

ProductDouble Use Compact SPF 15 gold deluxe edition Claire 1-2-3
Active ingredientZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Octinoxate 3.00% Sunscreen

Titanium Dioxide 6.24% Sunscreen

Zinc Oxide 4.90 % Sunscreen

OTC - PURPOSE SECTION

Uses:

Helps prevent Sunburn

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

Warnings:Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

Other information:

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

INACTIVE INGREDIENT SECTION

Inactive ingredients: Mica, polymethylsilsesquioxane, hdi/trimethylol hexyllactone crosspolymer, dimethicone, magnesium stearate, trimethylsiloxysilicate, isostearyl neopentanoate, hydrogen dimethicone, tocopheryl acetate, phenoxyethanol, alumina, triethoxycaprylylsilane, fragrance, caprylyl glycol, ceramide np, chlorphenesin, linalool, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

Product Labeling Claire 1-2-3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Labeling Claire 4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Labeling Medium 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Labeling Medium 6

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Labeling Medium 7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-201-01Double Use Compact SPF 15 gold deluxe edition Claire 1-2-310 g in 1 BOTTLEPOWDER104
14141-202-01Double Use Compact SPF 15 gold deluxe edition Claire 410 g in 1 BOTTLEPOWDER104
14141-203-01Double Use Compact SPF 15 gold deluxe edition Medium 510 g in 1 BOTTLEPOWDER104
14141-204-01Double Use Compact SPF 15 gold deluxe edition Medium 610 g in 1 BOTTLEPOWDER104
14141-205-01Double Use Compact SPF 15 gold deluxe edition Medium 710 g in 1 BOTTLEPOWDER104

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-20114141-201-01
14141-20214141-202-01
14141-20314141-203-01
14141-20414141-204-01
14141-20514141-205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 135 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENESINI670DAL4SZIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
CERAMIDE NP4370DF050BIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM STEARATE70097M6I30IACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
MICAV8A1AW0880IACT
LIMONENE, (+)-GFD7C86Q1WIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ALUMINUM OXIDELMI26O6933IACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
CHLORPHENESINI670DAL4SZIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
CERAMIDE NP4370DF050BIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
ndc (package): 14141-202-01
ndc (package): 14141-205-01
ndc (package): 14141-203-01
ndc (package): 14141-204-01
ndc (package): 14141-201-01
ndc (product): 14141-205
ndc (product): 14141-202
ndc (product): 14141-201
ndc (product): 14141-203
ndc (product): 14141-204
ndc11 (package): 14141020301
ndc11 (package): 14141020401
ndc11 (package): 14141020501
ndc11 (package): 14141020101
ndc11 (package): 14141020201
spl id: 3804885d-170e-97e6-e063-6294a90a59fc
spl set id: b3747373-ef67-89ff-e053-2995a90afcde

Reported adverse events (FAERS/openFDA)#

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