FDA.reportPublic FDA data

Sunscreen Mango and Coconut

Manufacturer
Kimberly-Clark Corporation
Effective date
2010-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:53

Label at a glance#

ProductSunscreen Mango and Coconut
Active ingredientAvobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Label structure11 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of activity in the water or sweating.

Dosage and administration

Apply generously 15 minutes before sun exposure and as needed. Reapply as needed or after towel drying, swimming or sweating. Ask a doctor before use on children under six months of age.

Storage and handling

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 0.8%, Oxybenzone 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of activity in the water or sweating.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

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 or irritation develops and lasts.

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 generously 15 minutes before sun exposure and as needed.
  • Reapply as needed or after towel drying, swimming or sweating.
  • Ask a doctor before use on children under six months of age.

Other information

STORAGE AND HANDLING SECTION

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Glycerin, Cetyl Phosphate, Caprylyl Glycol, Acrylates/C12 -22 Alkyl Methacrylate Copolymer, Dimethicone, Microcrystalline Cellulose, Phenoxyethanol, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, 1, 2- Hexanediol, Magnesium Aluminum Silicate, Cellulose Gum, Dimethiconol, Boron Nitride, Disodium EDTA, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Tropolone, Retinyl Palmitate, Tocopheryl Acetate, Fragrance/Parfum.

Questions?

OTC - QUESTIONS SECTION

1-877-546-2273 Mo–Fr, 8 am–4 pm CT. Serious side effects associated with the use of this product may be reported to this number.

SPL UNCLASSIFIED SECTION

Distributed by Kimberly-Clark
Global Sales, LLC, Neenah, WI
54956. Made in the U.S.

PRINCIPAL DISPLAY PANEL 44.4 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Waterproof

HUGGIES®

Little
Swimmers®

Sunscreen Lotion

SPF
50

MANGO & COCONUT
Aloe & Vitamins A&E

Long-Lasting
UVA/UVB Protection

1.5 FL OZ (44.4 mL)
20-78-256-1-00

Principal Display Panel
Principal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55118-600-112019-10-21C16284748780-1956f9ecf-d07d-621f-e053-dbdaa90a74adHuggies ® Little Swimmers ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55118-600-11Sunscreen Mango and Coconut45 g in 1 BOTTLE, PLASTICLOTION451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55118-600SUNSCREEN MANGO AND COCONUT (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [KIMBERLY-CLARK CORPORATION]1Legacy NDC, 1 package rows20100315_aff60363-62f7-476c-accb-032e28e82793.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55118-60055118-600-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB

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
858ce55b-2916-4778-bbfd-9e88cbb81c11aff60363-62f7-476c-accb-032e28e827932010-03-03WarningsExact identifier
spl id: 858ce55b-2916-4778-bbfd-9e88cbb81c11
spl set id: aff60363-62f7-476c-accb-032e28e82793

Reported adverse events (FAERS/openFDA)#

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