FDA.reportPublic FDA data

SPF50 Sunscreen

Manufacturer
Talent Brands Company LLC | Bridgeview Investments LLC | Derma Care researcg Labs, LLC
Effective date
2024-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:04

Label at a glance#

ProductSPF50 Sunscreen Cariposa
Active ingredientOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE
Label structure11 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. Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.  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 ...

Label contents#

Full prescribing information#

Active                                    ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21.6% ................Sunscreen

Purpose

OTC - PURPOSE SECTION

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

Do not use on

OTC - DO NOT USE SECTION

damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse eyes with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

• rash or irritation develops and lasts

Keep out of the 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. Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.  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 • children under 6 months of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Adipic Acid/Diglycol Crosspolymer, C12-15 Alkyl Benzoate,
Caprylyl Glycol, Isopropyl Myristate, Neopentyl Glycol
Diethylhexanoate, Neopentyl Glycol Diisostearate,
Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Silica,
Synthetic Wax, Tocopheryl Acetate, Triethoxycaprylylsilane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84267-005-01SPF50 SunscreenCariposa43 g in 1 CONTAINERSTICK431

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84267-005SPF50 SUNSCREEN CARIPOSA (ZINC OXIDE) STICK [TALENT BRANDS COMPANY LLC]1Current NDC, 1 package rows20240531_1938fa13-875a-140e-e063-6294a90a5514.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84267-00584267-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
C15-19 ALKANECI87N1IM01IACT
ETHYLHEXYL PALMITATE2865993309IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
SUNFLOWER OIL3W1JG795YIIACT
COCOA BUTTER512OYT1CRRIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
CETYL ALCOHOL936JST6JCNIACT
ALOEV5VD430YW9IACT
PARAFFINI9O0E3H2ZEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT

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
SPF50 Sunscreen CariposaZINC OXIDETalent Brands Company LLC1938fa13-875a-140e-e063-6294a90a55142024-05-24WarningsExact identifier
ndc (package): 84267-005-01
ndc (product): 84267-005
ndc11 (package): 84267000501
spl id: 1938fa13-875b-140e-e063-6294a90a5514
spl set id: 1938fa13-875a-140e-e063-6294a90a5514

Reported adverse events (FAERS/openFDA)#

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