SPF30 SUNSCREEN- avobenzone, homosalate, octocrylene, ocitsalate lotion

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]

Drug Facts

Active Ingredients

​Avobenzone 3%,

Homostate 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
• 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, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other information

Protect this product from excessive heat and direct sun

Questions?

Call toll free

Label

Package Labeling: (35mL 70412-231-35)

INGREDIENTS AND APPEARANCE

SPF30 SUNSCREEN 
avobenzone, homosalate, octocrylene, ocitsalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-231
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
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)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-231-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2018
2	NDC: 70412-231-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2018
3	NDC: 70412-231-45	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2018
4	NDC: 70412-231-53	53 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/01/2018
5	NDC: 70412-231-30	30 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2018
6	NDC: 70412-231-35	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2018
7	NDC: 70412-231-20	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co., Ltd.		544377996	manufacture(70412-231)