Sunscreen by Zhejiang Ayan Biotech Co.,Ltd. Sunscreen SPF30

Sunscreen by

Drug Labeling and Warnings

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]

SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide lotion 
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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Sunscreen SPF30

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:

Label

SUNSCREEN 
octinoxate, octisalate, oxybenzone, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70412-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 (400 CST) (UNII: 9OZ27X065D)  
PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70412-230-151 in 1 BOX01/24/201603/01/2020
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 70412-230-301 in 1 BOX01/24/201603/01/2020
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 70412-230-451 in 1 BOX01/24/201603/01/2020
345 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 70412-230-531 in 1 BOX01/24/201603/01/2020
453 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 70412-230-601 in 1 BOX01/24/201603/01/2020
560 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/24/201603/01/2020
Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Revised: 12/2019
 
Zhejiang Ayan Biotech Co.,Ltd.