FDA.reportPublic FDA data

C'est Moi It's Me Sunshine Mineral Sunscreen Lotion Broad Spectrum SPF 45

Manufacturer
Jakks Pacific, Inc
Effective date
2021-06-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:42:01

Label at a glance#

ProductCest Moi Sunshine Mineneral Sunscreen SPF45
Active ingredientZINC OXIDE
Label structure6 sections

Indications and uses

   Helps prevent sunburn If used as directed with other sun protection measures ( ​see Directions ​), deceases the risk of skin cancer and early skin aging caused by sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure reapply:    after 40 minutes of swimming or sweating    immediately after towel drying    at least every 2 hours children under 6 months:Ask a doctor ​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 scunscreen with a Broad Spectrum SPF value of 15 or higher and other s...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

  Zinc Oxide 19%

Purpose

OTC - PURPOSE SECTION

  Sunscreen

Uses

INDICATIONS & USAGE SECTION

  •    Helps prevent sunburn
  • If used as directed with other sun protection measures (​see Directions​), deceases the risk of skin cancer and early skin aging caused by sun.

Warnings

WARNINGS SECTION

For Exernal 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.

Stope use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

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.

Directions

DOSAGE FORMS & STRENGTHS SECTION

  • Apply liberally 15 minutes before sun exposure
  • reapply:
  •    after 40 minutes of swimming or sweating
  •    immediately after towel drying
  •    at least every 2 hours
  • children under 6 months:Ask a doctor
  • ​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 scunscreen 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf Juice, Beeswax, Caprylic/Capric Triglyceride, Cetearyl Nonanoate, Coco-Caprylate, Decylene Glycol, Fragaria Vesca (Strawberry) Fruit Extract, Glycerin, Hydrogenated Castor Oil, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyhydroxystearic Acid, Pyrus Malus (Apple) Fruit Extract, Shea Butter Ethyl Esters, Silica, Sodium Chloride, Squalane, Tocopherol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral sunscreen ctnMineral sunscreen ctn

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71965-41771965-417-01, 71965-417-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
KIWI FRUIT71ES77LGJCIACT
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL NONANOATEF6ZWV2F361IACT
COCO-CAPRYLATE4828G836N6IACT
FRAGARIA VESCA FRUITCG6IX3GCMUIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ISOSTEARIC ACIDX33R8U0062IACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-3 OLEATEXRQ165498BIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
APPLEB423VGH5S9IACT
SHEA BUTTER GLYCERETH-8 ESTERS47S52L53WZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SQUALANEGW89575KF9IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT

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
a41c9625-4d9f-4f04-af1d-1187da18b12197fa22a8-150d-41c9-90d3-afc3e0abcab32022-06-07WarningsExact identifier
spl set id: 97fa22a8-150d-41c9-90d3-afc3e0abcab3

Reported adverse events (FAERS/openFDA)#

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