ZERMAT SKIN SPF 50 BROAD SPECTRUM- avobenzone, homosalate, octinoxate, octisalate cream

Zermat Skin SPF 50 Broad Spectrum by

Drug Labeling and Warnings

Zermat Skin SPF 50 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Zermat Internacional S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Avobenzone..........3.00%

Homosalate..........10.00%

Octinoxate............7.50%

Octisalate..............5.00%

Sunscreen

Uses:

• Helps prevent sunburn,
• If used as directed with other sun protection measure (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 consult physician

If irritation

• or rash develops.

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.

Sun Protection Measures: 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 measures including:

• Limit time in the sun, especially between 10am and 2pm.
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6 months, consult a physician.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus
(Cucumber) Fruit Extract, Cyclotetrasiloxane, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Mangifera Indica (Mango) Seed Butter, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Soluble Collagen, Sorbitan
Olivate, Tocopheryl Acetate (Vitamin E), Zemea Propanediol.

Package Labeling:

INGREDIENTS AND APPEARANCE

ZERMAT SKIN SPF 50 BROAD SPECTRUM 
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15828-737
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15828-737-01	1 in 1 BOX	04/15/2016
1		48 g 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 not final	part352	04/15/2016

Labeler - Zermat Internacional S.A. de C.V. (812820712)