SUN SHIELD SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Winning Solutions

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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Winning Solutions (as PLD) - Sun Shield Sunscreen SPF 30 (66391-3001)

Active Ingredient

AVOBENZONE 2.0%

HOMOSALATE 10.0%

OCTISALATE 5.0%

OCTOCRYLENE 5.0%

OXYBENZONE 5.0%

Purpose

SUNSCREEN

Uses

Warnings

For external use only.

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control center right away.

Directions

Reapply:

Inactive ingredients

water, glycerin, stearic acid, cetyl alcohol, aloe barbadensis leaf, c12-15 alkyl benzoate, dea-cetyl phosphate, vp/eicosene copolymer, phenoxyethanol, dimethicone, triethanolamine, carbomer, titanium dioxide, glycereth-2 cocoate, tocopheryl acetate, retinyl palmitate, iodopropynyl butylcarbamate, chamomilla recutitita (matricaria) flower extract

01b LBL_Sun Shield SPF 30_30mL

SUN SHIELD SUNSCREEN  SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66391-3001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66391-3001-130 mL in 1 TUBE; Type 0: Not a Combination Product01/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/26/2023
Labeler - Winning Solutions (962718300)

Revised: 1/2023
Document Id: f33361a7-e049-4681-e053-2a95a90ab909
Set id: f332a0b6-639b-3f46-e053-2995a90a7966
Version: 2
Effective Time: 20230126
 
Winning Solutions