Spf30 sunscreen lotion

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 NOTskin cancer or early skin aging. this product is NOTwater 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 medicalhelp 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 increasesyour risk of skin cancer and early skin aging. To decrease this
    risk, regularly use a sunscreen with Broad Spectrum SPF valueof 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 CetylPhosphate, 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

Spl unclassified section

Ingredients and appearance - Product information

Spf30 sunscreen lotion- Avobenzone, homosalate, octocrylene, ocitsalate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70412-231
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Avobenzone ( UNII: G63QQF2NOX)( Avobenzone - UNII: G63QQF2NOX ) 30 mgin 1 mL
Homosalate ( UNII: V06SV4M95S)( Homosalate - UNII: V06SV4M95S ) 100 mgin 1 mL
Octocrylene ( UNII: 5A68WGF6WM)( Octocrylene - UNII: 5A68WGF6WM ) 100 mgin 1 mL
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 50 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 70412-231-15 15mL in 1 BOTTLE 2018/07/01
2 NDC: 70412-231-60 60mL in 1 BOTTLE 2018/07/01
3 NDC: 70412-231-45 45mL in 1 BOTTLE 2018/07/01
4 NDC: 70412-231-53 53mL in 1 BOTTLE 2018/07/01
5 NDC: 70412-231-30 30mL in 1 PACKAGE 2018/07/01
6 NDC: 70412-231-35 35mL in 1 BOTTLE 2018/07/01
7 NDC: 70412-231-20 20mL in 1 BOTTLE 2018/07/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part352 USA 2018/07/01

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

Establishment

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

Label

Package labeling: (35ml 70412-231-35)