FDA.reportPublic FDA data

CALIFORNIA MANGO SPF-50 SUNSCREEN

Manufacturer
CALMANGO, INC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:53

Label at a glance#

ProductCALIFORNIA MANGO SPF-50 SUNSCREEN
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of swmming or sweating. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 the risk, regularly use a suncreen with broad spectrum SPF of 15 or higher and other s...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.0%), Octisalate (5.0%), Octocrylene (10.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swmming or sweating.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a suncreen with broad spectrum SPF 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 sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranante) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions?

OTC - QUESTIONS SECTION

Call toll free or 800-656-2646 562-946-4170

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83453-406-00CALIFORNIA MANGO SPF-50 SUNSCREEN177 mL in 1 BOTTLE, SPRAYLIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83453-406CALIFORNIA MANGO SPF-50 SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LIQUID [CALMANGO, INC]2Current NDC, 1 package rows20231106_183e523a-93ee-47ec-8bd4-5557af449ea5.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83453-40683453-406-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
KIWI FRUIT71ES77LGJCIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SAFFLOWER4VBL71TY4YIACT
COCONUT OILQ9L0O73W7LIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
FLAX SEED4110YT348CIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
CALIFORNIA MANGO SPF-50 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INC183e523a-93ee-47ec-8bd4-5557af449ea52023-11-06WarningsExact identifier
ndc (package): 83453-406-00
ndc (product): 83453-406
ndc11 (package): 83453040600
spl id: 09769ae3-d1a0-e2dd-e063-6294a90a1f64
spl set id: 183e523a-93ee-47ec-8bd4-5557af449ea5

Reported adverse events (FAERS/openFDA)#

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