AMBI EVEN AND CLEAR FACIAL MOISTURIZER SPF-30- avobenzone, octisalate, octocrylene cream

AMBI Even and Clear Facial Moisturizer SPF-30 by

Drug Labeling and Warnings

AMBI Even and Clear Facial Moisturizer SPF-30 by is a Otc medication manufactured, distributed, or labeled by AMBI Enterprises LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active ingredients:

Avobenzone 3% Octisalate 5% Octocrylene 5%

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.
• Higher SPF gives more sunburn protection

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 consult a doctor if

rash or irritation develops and lasts.

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

If product is swallowed, get medical attention or contact Poison Control Center immediately.

Directions:

• Apply liberally 15-minutes before sun exposure.
• Reapply:
• At least every two-hours.
• Immediately after swimming, sweating or towel drying.
• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection and other sun measures including: SUN PROTECTION MEASURES:
• Limit time in the sun, especially between 10 am and 2 pm.
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6-months, consult a physician.

Inactive ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctostaphylos Uva Ursi (Bearberry) Leaf Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Cucumis Sativa (Cucumber) Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extarct, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Saccharide Isomerate, Silica, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

Other information:

Protect this product from excessive heat and direct sunlight.

Questions or comments?

1-800-946-6354

Package Labeling:

INGREDIENTS AND APPEARANCE

AMBI EVEN AND CLEAR FACIAL MOISTURIZER SPF-30 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73453-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73453-233-00	1 in 1 BOX	09/25/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/25/2021

Labeler - AMBI Enterprises LLC (117015229)