ANEW PLATINUM DAY- octinoxate, octisalate, oxybenzone, avobenzone cream 
Avon Products, Inc.

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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Active ingredients

OCTINOXATE 7.5%, OCTISALATE 4.75%,

OXYBENZONE 4.0%, AVOBENZONE 2.85%..................................

Purpose

............................Sunscreen

Uses
• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

protect the product in this container from excessive heat and direct sun

Inactive ingredients: WATER, GLYCERIN, SILICA, DIMETHICONE, STEARIC ACID, STEARYL ALCOHOL, NONENOL, SAPINDUS RARAK FRUIT EXTRACT, POUZOLZIA PENTANDRA EXTRACT, METHOXYBENZOYL METHYLSULFONYL OXOPIPERIDINYL PIPERAZINECARBOXAMIDE, THIAZOLYLALANINE, SACCHAROMYCES/PLATINUM FERMENT, TRISILOXANE, DIMETHICONOL, MYRISTYL MYRISTATE, MALTODEXTRIN, PEG-100 STEARATE, CAPRYLYL GLYCOL,GLYCERYL STEARATE, SODIUM POLYACRYLATE, POLYURETHANE-40, POTASSIUM HYDROXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, 1,2-HEXANEDIOL, PARFUM.

image of PDPimage of DFB

ANEW  PLATINUM DAY
octinoxate, octisalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71110-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
THIAZOLYLALANINE (UNII: VTL1Y3S44B)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71110-0009-11.1 g in 1 PACKET; Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2016
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Manufacturing (Guangzhou) Ltd544863277manufacture(71110-0009)

Revised: 6/2018
Document Id: 6d95fbea-127f-1719-e053-2a91aa0a0086
Set id: 6d95b59a-9af2-baa2-e053-2991aa0aaa24
Version: 1
Effective Time: 20180601
 
Avon Products, Inc.