ALAFFIA FACE- zinc oxide cream

Alaffia Face by

Drug Labeling and Warnings

Alaffia Face by is a Otc medication manufactured, distributed, or labeled by Agbanga Karite LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 10%

Purpose

Sunscreen

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

Warnings

● For external use only

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

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

Directions

● 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

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

Inactive ingredients

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?

Call 360-866-0080

Product Label

INGREDIENTS AND APPEARANCE

ALAFFIA FACE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51441-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PAPAYA (UNII: KU94FIY6JB)
COCONUT OIL (UNII: Q9L0O73W7L)
COCONUT WATER (UNII: 267F5Y81NT)
LAVENDER OIL (UNII: ZBP1YXW0H8)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51441-004-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2019

Labeler - Agbanga Karite LLC (614221104)

Establishment
Name	Address	ID/FEI	Business Operations
Agbanga Karite LLC		614221104	manufacture(51441-004)