FDA.reportPublic FDA data

KISS MY FACE SPF-50 Baby Mineral Sunscreen

Manufacturer
WINDMILL HEALTH PRODUCTS LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:13

Label at a glance#

ProductKISS MY FACE SPF-50 Baby Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minute before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including: Sun Protection ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide - 12.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

not intended for ingestion. 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

  • skin 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 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 minute before sun exposure.
  • Reapply:
  • after 80 minutes of swimming or sweating,
  • immediately after towel drying and
  • at least every 2 hours.
  • Children under 6 months: ask a doctor.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including: Sun Protection Measures:
  • Limit time in sun, especially from 10am to 2pm.
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extarct, Citric Acid, Daucus Carota Sative (Carrot) Extract, Decyl Glucoside, Dehydroacetic Acid, Fucus Vesiculosus (Algae) Extract, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Tagetes Erecta(Lutin) Extract, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74154-317-00KISS MY FACE SPF-50 Baby Mineral Sunscreen118 mL in 1 TUBECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74154-317KISS MY FACE SPF-50 BABY MINERAL SUNSCREEN (ZINC OXIDE) CREAM [WINDMILL HEALTH PRODUCTS LLC]2Current NDC, Legacy NDC, 1 package rows20231112_ac66ad82-a01f-4e44-92a7-b5ab5bd30922.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74154-31774154-317-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCONUT OILQ9L0O73W7LIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARROTL56Z1JK48BIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DEHYDROACETIC ACID2KAG279R6RIACT
FUCUS VESICULOSUS535G2ABX9MIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
KISS MY FACE SPF-50 Baby Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCac66ad82-a01f-4e44-92a7-b5ab5bd309222023-11-11WarningsExact identifier
ndc (package): 74154-317-00
ndc (product): 74154-317
ndc11 (package): 74154031700
spl id: 09e2089e-a6fa-9d2f-e063-6394a90a2282
spl set id: ac66ad82-a01f-4e44-92a7-b5ab5bd30922

Reported adverse events (FAERS/openFDA)#

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