Alaffia Face Lotion

Manufacturer
Agbanga Karite LLC
Effective date
2020-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:09:24

Label at a glance#

ProductAlaffia Face
Active ingredientZINC OXIDE
Label structure14 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 generously to face and neck 15 minutes before sun exposure. ▪ Children under 6 months of age: Ask a doctor. ● Reapply at least every 2 hours.  Use a water-resistant sunscreen if swimming or sweating. ● 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 of 15 or higher and othe...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%

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

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

OTC - STOP USE SECTION

if rash occurs.

Keep out of 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 generously to face and neck 15 minutes before sun exposure. ▪ Children under 6 months of age: Ask a doctor. ● Reapply at least every 2 hours.  Use a water-resistant sunscreen if swimming or sweating. ● 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 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-sleeve shirts, pants, hats, and sunglasses

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Azadirachta indica (Neem) Leaf Aqueous Extract, Carica Papaya (Papaya) Leaf Aqueous Extract, Cocos nucifera (Coconut) Oil, Cocos nucifera (Coconut) Water, Emulsifying Wax, Cocos nucifera (Coconut) Oil, Cocos nuicifera (Coconut Water), Emulsifying Wax, Cocos nucifera (Coconut) Extract, Lavandula hybrida (Lavender) Oil, Stearic Acid, Phenoxyethanol, Glycerin, Potassium Sorbate, Ascorbic Acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 360-866-0080

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EveryDayCoconutEveryDayCoconut

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51441-00451441-004-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
b2d3e278-aaec-a055-e053-2a95a90a6b03986ec2c7-5d8d-4455-8268-a4bef32f4fdf2020-10-29WarningsExact identifier
spl id: b2d3e278-aaec-a055-e053-2a95a90a6b03
spl set id: 986ec2c7-5d8d-4455-8268-a4bef32f4fdf

Reported adverse events (FAERS/openFDA)#

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