SPF30 SUNSCREEN- avobenzone, homosalate, octocrylene, ocitsalate spray

SPF30 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

​Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer 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

inactive ingredients.

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

Label

INGREDIENTS AND APPEARANCE

SPF30 SUNSCREEN 
avobenzone, homosalate, octocrylene, ocitsalate spray

Product Information
Product Type	HUMAN OTC DRUG	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 CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
COCONUT (UNII: 3RT3536DHY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-238-08	8 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018
2	NDC: 70412-238-20	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018
3	NDC: 70412-238-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018
4	NDC: 70412-238-30	30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	06/01/2018
5	NDC: 70412-238-10	10 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/01/2018
6	NDC: 70412-238-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

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

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