SPF30 SUNSCREEN AND ANTIBACTERIAL HAND SANITIZER- alcohol, avobenzone, homosalate, octocrylene, octisalate kit

SPF30 Sunscreen and Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

SPF30 Sunscreen and Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ayan Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Antibacterial Hand Sanitizer

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.

WARNINGS:

For external use only.
Flammable. Keep away from fire or flame.

Do not apply around eyes,

Do not use

in ears & mouth.   

When using this product

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor

if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry

Inactive ingredients.

water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, carbomer, fragrance.

Other Information

Store at room temperature 15°C to 30°C (59° F to 86° F)

Questions?

Call

Drug Facts SPF30 Sunscreeen Spray

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octocrylene10%, Octisalate 5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn NOT skin cancer or early skin aging. This product is NOT water resistant or sweat resistant.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Non-Water Resistant Product
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. to 2 p.m.
Wear long sleeve shirts, pants, hats and sunglasses.

Inactive ingredients.

Water, Glycerin, Potassium Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25 Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA

Other information

Protect this product from excessive heat and direct sun

Questions?

Call

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF30 SUNSCREEN AND ANTIBACTERIAL HAND SANITIZER 
alcohol, avobenzone, homosalate, octocrylene, octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-817

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-817-05	1 in 1 KIT	09/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	5 mL
Part 2	1 TUBE	5 mL

Part 1 of 2

ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol spray

Product Information
Item Code (Source)	NDC: 70412-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-119-05	5 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 not final	part333E	09/01/2018

Part 2 of 2

SPF30 SUNSCREEN 
avobenzone, homosalate, octocrylene, ocitsalate spray

Product Information
Item Code (Source)	NDC: 70412-238
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-238-05	5 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 not final	part352	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2018

Labeler - Zhejiang Ayan Biotech Co., Ltd. (544377996)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co., Ltd.		544377996	manufacture(70412-817, 70412-119, 70412-238)