SPF 30 Sunscreen by Zhejiang Ayan Biotech Co.,Ltd. SPF 30 Sunscreen

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 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]

SPF 30 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide spray 
Zhejiang Ayan Biotech Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF 30 Sunscreen

Drug Facts

Active Ingredients

Octinoxate 7.5%

Octisalate 2.0%

Oxybenzone 4.0%

Titanium Dioxide 2.5%

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 our 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

C12-15 Alkyl Benzoate, Ceteareth-25, Cetearyl Alcohol, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Myristyl Propionate, PEG-15 Cocomonium Chloride, PEG-9 Dimethicone, Propylene Glycol Dioleate,Water, Xanthan Gum.

Other information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free

Package Labeling

SPF 30 SUNSCREEN 
octinoxate, octisalate, oxybenzone, titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MYRISTYL PROPIONATE (UNII: P59053E7NJ)
PEG-9 DIMETHICONE (UNII: 9OZ27X065D)
PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-239-08	1 in 1 CARTON	02/04/2016	03/01/2020
1		8 mL in 1 BOTTLE, SPRAY; 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	02/04/2016	03/01/2020

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

Revised: 12/2019

Document Id: 9a9d5f6f-6ba8-4777-e053-2a95a90a4ff9

34390-5

Set id: 31ec737e-0878-4eba-bf8e-e8534e23017d

Version: 4

Effective Time: 20191226

 

Zhejiang Ayan Biotech Co.,Ltd.